Karnataka fake drug racket: 16 licences cancelled, eight suspended including Pfizer depot

The Karnataka Food Safety and Drugs Administration (FDA) has cancelled 16 drug licences and suspended eight others, including the wholesale licence of a Pfizer depot, as it widens its investigation into an alleged racket involving the repacking and sale of spurious medicines.

The regulatory action follows an August 18 raid by the FDA’s Drug Enforcement Wing at a farmhouse in Kurubarakeranahalli near Bidadi in Bengaluru South district. Officials seized suspected spurious medicines, machinery, packaging material and forged labels valued at around Rs 5.05 crore from the premises.

Preliminary investigation indicated that the facility was allegedly being used to procure cheaper medicines from other states, transfer them into new vials and relabel them as expensive life-saving drugs sold under multinational pharmaceutical brands.

24 licences face action

As investigators traced the suspected distribution network, the FDA cancelled the licences of 16 retail and wholesale establishments and suspended those of eight others.

Among the eight suspended licences is the wholesale licence of Pfizer Ltd’s C&F depot at Kempanalinganahalli in Nelamangala taluk of Bengaluru Rural district. The other establishments whose licences were suspended include Med Pharma, Surya Speciality Hospital, Sagar Pharma Unit-II, Vivantha Pharmaceuticals, Maruthi Medicals, Viva Pharma and Hi-5 Pharma.

The suspension of Pfizer’s depot licence is part of the regulator’s action against establishments identified during its supply-chain investigation and does not, by itself, establish that Pfizer manufactured the suspected counterfeit medicines.

The 16 establishments whose licences were cancelled include wholesalers and retailers in Bengaluru and Hubballi. The FDA said its investigation was examining the movement of the suspected drugs through the supply chain and the role of establishments allegedly involved in their sale or distribution.

Fake labels, QR codes found

Officials said the seized material included thousands of injectable medicine vials as well as expired drugs, an injection-filling machine and forged labels and stamps.

Among the stock were 5,640 vials labelled CEFIAVIGENT 2.5 Injection, valued at Rs 3.38 crore, and 1,531 vials of HIZLAM Injectables worth Rs 52.24 lakh. Investigators also seized 470 vials of Xavitaz Injection, 264 vials labelled EMBLAVEO and 165 vials of Zavicefta Injection, besides other injectable medicines.

The suspected counterfeit labels included QR and scanning codes that investigators found to be non-functional during verification.

The discovery of 30 boxes of expired medicines, valued at around Rs 35 lakh, has also prompted investigators to examine whether expired products were being reintroduced into the supply chain after repackaging.

Samples sent for testing

Samples of the seized medicines have been sent for laboratory analysis to establish their chemical composition, sterility and potency. The FDA has also begun blocking the relevant batch numbers and entries on its portal to prevent further distribution or sale.

The alleged operation involved the manufacture, storage and distribution of medicines without the licences required under the Drugs and Cosmetics Act, 1940. A criminal case has been registered, while a Special Investigation Team is tracing the wider supply network and those allegedly involved in the racket.

Investigators are also examining links to hospitals, clinics, pharmacies and distributors after the probe indicated that the suspected supply network may have extended across multiple establishments.

The FDA has advised patients to purchase medicines only from licensed pharmacies, obtain valid invoices and report suspicious packaging or QR codes that fail to scan.