FDA cancels 16, suspends eight drug licences in Karnataka

The Karnataka Food Safety and Drugs Administration cancelled 16 drug licences and suspended eight others as its investigation into a suspected counterfeit medicine network near Bidadi expands to pharmacies and wholesalers. Among the suspended licences is the wholesale licence of Pfizer Ltd in Bengaluru Rural district.

The action follows the FDA’s August 18 raid on an unlicensed facility in Kurubarakeranahalli, near Bidadi, where officials seized medicines, machinery, packaging material and forged labels worth ₹5.05 crore.

The 16 cancelled licences include those held by Avesco Healthcare, Bangalore Speciality Pharma, Bengaluru Speciality Pharma, Patel Medi Trade, Rajarajeshwari Pharma, N.S. Pharma, Surya Specialty Pharma, SWS Pharma, Krupa Healthcare, St. Philomena Hospital Drug Centre, Sagar Pharma, Zymus Pharma, Fortune Medical Solutions, Excelcare Pharma, Patel Medicals and another Bangalore Speciality Pharma outlet.

The eight suspended licences belong to Med Pharma, Surya Speciality Hospital, Sagar Pharma Unit-II, Vivantha Pharmaceuticals, Maruthi Medicals, Viva Pharma, Hi-5 Pharma and Pfizer Ltd.

The Pfizer wholesale licence at Kempanalinganahalli village in Nelamangala taluk, Bengaluru Rural district, has also been suspended.

The FDA blocked the batch numbers of medicines seized during the raid on its portal and sent samples for laboratory testing. “The batch numbers and entries for the seized drugs are being blocked on the Karnataka FDA portal to prevent any further distribution or sale,” the department said.

“Samples of the seized products have been sent for laboratory testing to verify their chemical composition, sterility, and potency,” it added.

The investigation began after the Drug Enforcement Wing received a tip-off about the facility. “Preliminary investigations revealed that the premises were being used to procure low-cost medications from neighbouring states. These cheaper drugs were allegedly refilled into new vials and relabelled to counterfeit expensive life-saving brands of multinational corporations (MNCs), specifically imitating imported products under the brand name ‘Pfizer’,” the FDA said.

The seized stock included 5,640 vials of CEFIAVIGENT 2.5 Injection valued at ₹3.38 crore, 1,531 vials of HIZLAM Injectables worth ₹52.24 lakh, 30 boxes of expired drugs worth ₹35 lakh and 470 vials of Xavitaz Inj. valued at ₹27.49 lakh.

Officials also recovered 264 vials of EMBLAVEO carrying the name Pfizer Ltd and valued at ₹20.59 lakh, along with 165 vials of Zavicefta Inj., 44 vials each of TIGYNT IV and Tigvnet injections, 190 vials of Aztreo Inj. and 50 vials of Trezam Inj. Several of the seized medicines are injectable antibiotics used to treat serious bacterial infections.

The counterfeit labels carried QR and scanning codes that failed when checked by investigators. “To deceive buyers and maximize illicit profits, the counterfeit labels featured QR/scanning codes, which were found to be completely nonfunctional upon verification,” the FDA said.

The raid also yielded packaging components, an injection filling machine worth ₹7 lakh and forged labels and stamps valued at ₹14 lakh. The seizure of expired medicines raised concerns that such stock could have been reintroduced into the supply chain.

The FDA said the suspected drugs could pose a serious health risk because their contents might not match the labels. “These spurious drugs contain no active medicinal components, the wrong ingredients, or toxic substances, posing a fatal threat to public health,” the department said.

The facility was allegedly operating without the licences required under the Drugs and Cosmetics Act, 1940. The FDA has registered a criminal case and said the suspected medicines fall under the definition of spurious drugs under section 17B, with their manufacture, sale, stocking and distribution punishable under section 27.

A Special Investigation Team (SIT) has now widened the probe to trace the supply chain and identify those involved in obtaining, distributing and selling the medicines. “The entire stock of seized spurious drugs, machinery, and printing materials is being officially documented and will be produced before the JMFC Court, Bangalore South, for further legal proceedings. A Special Investigation Team (SIT) has extended the probe to trace the supply chain, and coordinated efforts are underway to arrest all the accused individuals behind this syndicate shortly,” the FDA said.

The department has asked patients to buy life-saving medicines only from licensed pharmacies against valid tax invoices and report suspicious packaging or QR codes that fail to scan.