Counterfeit drug racket: Karnataka FDA cancels licences of 16 firms, suspends eight others including Pfizer
The FDA said it has moved to contain the suspected counterfeit medicine supply chain by blocking the batch numbers and entries of the seized medicines on its portal.
Synopsis:Karnataka FDA has cancelled the licences of 16 establishments and suspended those of eight others over involvement in an alleged counterfeit drug racket. The action followed the seizure of medicines, machinery and forged labels worth Rs 5.05 crore in Bengaluru. The seized drugs have been sent for laboratory testing, while an SIT continues investigating.
The Karnataka Food Safety and Drugs Administration (FDA) has cancelled the licences of 16 establishments allegedly involved in the manufacturing and trading of counterfeit medicines. It also suspended the wholesale and retail licences of eight other firms, including Pfizer Ltd’s C&F depot in Nelamangala.
The action was taken as part of the ongoing investigation into a suspected racket involved in the sale and supply of spurious drugs by the Bengaluru Police’s Special Investigation Team (SIT) and the Drugs Control Department.
The investigation was initiated after the FDA’s Drug Enforcement Wing seized counterfeit drugs, industrial machinery and other materials valued at Rs 5.05 crore during a raid at a farmhouse in Kurubarakeranahalli, Bidadi, Bengaluru South district on August 18.
According to a statement issued by the FDA Commissioner on Sunday, September 20, the establishments were allegedly involved in procuring cheaper medicines from neighbouring states, refilling them into new vials and passing them off as expensive life-saving medicines.
“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’,” he said.
The Commissioner said the alleged counterfeit operation also involved forged labels carrying QR or scanning codes.
“To deceive buyers and maximise illicit profits, the counterfeit labels featured QR/scanning codes, which were found to be completely nonfunctional upon verification.”
The department said such spurious medicines could pose a serious risk to patients.
“These spurious drugs contain no active medicinal components, the wrong ingredients, or toxic substances, posing a fatal threat to public health.”
Pfizer depot among eight establishments facing suspension
The FDA’s list of establishments facing action includes M/s Pfizer Ltd, located in Kempalinganahalli village in Bengaluru Rural district, whose wholesale licence has been suspended.
The press note separately states that the licence of M/s Pfizer C&F Depot, located at the same premises, has also been suspended.
The other seven establishments whose licences were suspended are Med Pharma, Surya Speciality Hospital, Sagar Pharma Unit-II, Vivantha Pharmaceuticals, Maruthi Medicals, Viva Pharma and Hi-5 Pharma.
Meanwhile, the licences of 16 establishments have been cancelled, including those of wholesalers, retailers and establishments holding both wholesale and retail licences.
Cancer-care angle
The seized inventory includes Hizlam Injectables, Xavitaz Injection, Emblaveo and Zavicefta Injection, along with several other injectable medicines. The FDA’s press note identifies them as part of the seized stock but does not specifically classify these medicines as cancer-care drugs.
The department, however, described the products involved in the alleged racket as expensive “life-saving” medicines.
The seized material included 5,640 vials of CEFIAVIGENT 2.5 Injection, valued at ₹3.38 crore, and 1,531 vials of HIZLAM Injectables, valued at ₹52.24 lakh.
The FDA also seized 30 boxes of expired drugs valued at ₹35 lakh, 470 vials of Xavitaz Injection worth ₹27.49 lakh, 264 vials of Emblaveo worth ₹20.59 lakh and 165 vials of Zavicefta worth ₹5.45 lakh.
Other seized products included TIGYNT IV, Tigvnet, Aztreo and Trezam injections.
The operation also uncovered packaging components, an injection-filling machine and forged labels and stamps. The FDA’s inventory values the injection-filling machinery at ₹7 lakh and forged labels and stamps at ₹14 lakh. The final total in the inventory is ₹5,05,49,575.
The FDA said it has moved to contain the suspected supply chain by blocking the batch numbers and entries of the seized medicines on its portal.
“The batch numbers and entries for the seized drugs are being blocked on the Karnataka FDA portal to prevent any further distribution or sale,” it said.
“Samples of the seized products have been sent for laboratory testing to verify their chemical composition, sterility and potency,” it added.
The department said the operation involved the manufacture, storage and distribution of medicines without a licence.
“The operation directly violated the Drugs and Cosmetics Act, 1940, specifically concerning the manufacture, storage and distribution of drugs without any licence,” it said.
The department also flagged the alleged relabelling of cheaper medicines as premium products.
“By relabelling generic or lower-cost drugs as premium brands, the perpetrators created significant risks regarding the authenticity and safety of the medication provided to patients,” it said.
The seizure of expired medicines was another concern.
“The seizure of 30 boxes of expired medications suggests that expired drugs were being reintegrated into the supply chain, posing a severe health hazard to the public,” the department said.
The FDA said a criminal case has been registered under the Drugs and Cosmetics Act, 1940. The department said counterfeit and fake medicines are classified as spurious drugs under Section 17B, while Section 27 provides for stringent punishment for their manufacture, sale, stocking or distribution.
According to the Commissioner, “Conviction under this section carries a severe penalty ranging from a minimum of 10 years of rigorous imprisonment up to life imprisonment, along with hefty fines.”
The seized drugs, machinery and printing materials will be produced before the JMFC Court in Bengaluru South, while the investigation continues.
“The 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 department said.
The department has also advised patients to buy life-saving medicines only from licensed pharmacies and against valid tax invoices.
“Any suspicious variations in packaging or non-scanning QR codes on drug labels should be immediately reported to the drug enforcement authorities,” it said.