FDA cancels 16, suspends 8 drug licences in K’taka

The Karnataka food safety and drugs administration (FDA) on Sunday said it has cancelled 16 drug licences and suspended eight others as its investigation into a suspected counterfeit medicine network near Bidadi expands to pharmacies and wholesalers.

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 FDA has 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, specifically imitating imported products under the brand name ‘Pfizer’,” the FDA said in a release.

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 facility was allegedly operating without 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 17 B, with manufacture, sale, stocking and distribution punishable under Section 27.

The licence of M/s Pfizer C & F Depot, Survey No. 66/3 B2, Kempalinganahalli, Nelamangala taluk, Bengaluru Rural district, has also been suspended, it said.

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 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.

Arun Dev is an Assistant Editor with the Karnataka bureau of Hindustan Times. A journalist for over 10 years, he has written extensively on crime and politics.