Karnataka FDA Cancels 16 Drug Licences, Suspends 8 Over Fake Medicine Case

The Karnataka Food Safety and Drugs Administration (FDA) has cancelled 16 drug licences and suspended eight others as authorities step up action against an alleged counterfeit medicine network in the state. The action follows a raid conducted on August 18 at an allegedly unauthorised facility near Kurubarakeranahalli in Bidadi. Officials said medicines, expired drugs, packaging material and equipment were recovered during the operation, with the total value of the seized material estimated at around ₹5.05 crore.

According to officials, the investigation began after the FDA's Drug Enforcement Wing received information about the facility. Investigators suspect that lower-cost medicines sourced from outside Karnataka were being repackaged and relabelled as higher-value medicines. The raid reportedly resulted in the seizure of thousands of medicine vials, along with expired stocks and equipment allegedly used in the repackaging process. Authorities are examining the seized products to determine their composition, quality, sterility and potency.

The FDA has also widened its investigation to pharmacies, wholesalers and other businesses that may have handled the suspected medicines. Officials have cancelled the licences of several establishments and suspended eight others as part of the ongoing probe. Authorities have blocked the identified medicine batches on the FDA portal and sent samples to government laboratories for testing. The laboratory results are expected to help investigators determine whether the medicines contained the ingredients stated on their labels and met prescribed quality standards.

A criminal case has been registered under the Drugs and Cosmetics Act, 1940. A Special Investigation Team is also examining the suspected supply chain to establish the source of the medicines and identify those involved in their alleged manufacture, repackaging, storage and distribution. Karnataka authorities have indicated that the investigation may extend beyond the state if links to an interstate supply network are established.

The case has also prompted scrutiny of medicine distribution channels, particularly because some of the products under investigation are injectable medicines. Authorities have advised consumers to buy medicines only from licensed pharmacies and retain purchase bills so that products can be traced if concerns arise. The investigation remains underway, with further action expected after laboratory reports and supply-chain inquiries are completed.