The Karnataka Food Safety and Drugs Administration on September 18 cancelled the licences of 16 retail and wholesale pharmaceutical firms across Bengaluru. It suspended the licences of eight others, including pharma major Pfizer’s depot.
The Karnataka High Court on Monday stayed the Food Safety and Drug Administration (FSDA) order cancelling Fortune Medical Solutions’ licence and suspending Vivanta Pharmaceuticals’ licence for allegedly selling spurious products.
The Karnataka Food Safety and Drugs Administration (FSDA) on September 18, cancelled the licences of 16 retail and wholesale pharmaceutical firms across Bengaluru and suspended those of eight others, including global pharma major Pfizer’s depot, as they violated Rule 66 of the Drugs and Cosmetics Rules, 1945.
Rule 66 provides for an opportunity of hearing and explanation to the party against whom action is proposed before suspending or cancelling the licence.
Justice C M Poonacha said, “The petitioner shall also be permitted to carry on its pharmaceutical distribution business till the next date of hearing in accordance with law. This order will not preclude the respondents from taking such measures as may be permissible under law and petitioner shall cooperate with the authorities in any action that is undertaken in accordance with law,” the court said.
The court issued notice to FSDA and others and directed them to file their reply to the petitions.
The petitions are now posted for hearing on October 9.
Additional Government Advocate Rahul Cariappa said the court will hear together all 16 petitions filed by similarly placed pharma companies on October 9.
FSDAI’s action follows raids at farmhouses in the Bidadi and Dodderi areas of Bengaluru South district on August 18. The agency seized suspected counterfeit medicines worth around Rs 5 crore, along with fake bills, injection-filling equipment and counterfeit labels. Later, a Special Investigation Team (SIT) was formed to probe the wider racket.
According to the FSDA, preliminary investigations revealed that the farmhouse 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’.
To deceive buyers and maximise illicit profits, the counterfeit labels featured QR/scanning codes that the FSDA found completely non-functional upon verification. These counterfeit drugs lack active medicinal ingredients and may contain harmful substances, the agency had noted.
In its petition, Vivanta Pharma claimed that the allegations only relate to identified batches of Zavicefta, whereas the impugned order suspended all the drug licences of the petitioner from carrying on its business and violates its fundamental right. Further, the blanket order is excessive, arbitrary, and disproportionate.
Firms whose licences were cancelled
Avesco Healthcare, Bangalore Speciali Pharma, Patel Medi Trade, Rajarajeshwari Pharma, Surya Speciality Pharma, SWS Pharma, Krupa Healthcare, St Philomena Hospital Drug Centre, Sagar Pharma, Zymus Pharma, Fortune Medical Solutions, Excelcare Pharma, Patel Medicals, and Bangalore Speciality Pharma outlet at Chamarajpet.
Firms whose licences were suspended
Med Pharma, Surya Speciality Hospital, Sagar Pharma (Unit-II), Vivantha Pharmaceuticals, Maruthi Medicals, Viva Pharma (Belagavi), Hi-5 Pharma, and Pfizer.
Seized materials
– 5,640 vials of counterfeit Cefiavigent 2.5 injection, falsely branded under Eucratia Healthcare Pvt Ltd, valued at over Rs 3.38 crore, the single largest component of the haul.
– 1,531 vials of Hizlam injectables, falsely attributed to Welcure Remedies (Rs 52.24 lakh).
– 264 vials of Emblaveo, counterfeiting Pfizer (Rs 20.59 lakh).
– 30 boxes of expired medications, valued at Rs 35 lakh, which officials say were apparently being prepared for reintroduction into the market.
– Several other counterfeit injectable batches, including Xavitaz, Zavicefta, Tigynt, Tigvnet, Aztreo, and Trezam, along with packaging components, an injection-filling machine, and bulk quantities of forged labels and stamps.
