The Karnataka High Court has stayed regulatory orders that cancelled the licence of Fortune Medical Solutions and suspended the permit of Vivanta Pharmaceuticals over allegations of dealing in spurious medicines, granting both distributors interim permission to resume business.
Justice C M Poonacha issued the interim direction on Monday, allowing the two distributors to continue operations in accordance with the law until the next hearing date, scheduled for Oct. 9. The bench clarified that the stay does not prevent state authorities from taking lawful measures, provided the distributors cooperate with any statutory proceedings.
The court issued notices directing the Food Safety and Drugs Administration (FSDA) and other respondents to submit formal replies. Additional Government Advocate Rahul Cariappa informed the court that 16 petitions filed by similarly placed pharmaceutical distributors will be heard together on Oct. 9.
Distributor Alleges Disproportionate Regulatory Action
The legal challenge by Vivanta Pharmaceuticals argued that regulatory allegations pertained strictly to specific batches of the injectable drug Zavicefta. In its plea, the distributor contended that a blanket suspension covering all of its drug licences violated its fundamental rights and characterized the enforcement action as excessive, arbitrary, and disproportionate.
The court’s interim ruling follows sweeping enforcement actions executed by the Karnataka FSDA on Sept. 18, when the regulator cancelled licences of 16 retail and wholesale pharmaceutical firms across Bengaluru and suspended permits of eight others, including a depot operated by multinational pharmaceutical manufacturer Pfizer.
The regulatory body initiated the penalties citing violations of Rule 66 of the Drugs and Cosmetics Rules, 1945, which mandates that authorities must grant a licensee an opportunity to be heard and present an explanation before an order of suspension or cancellation is enacted.
Crackdown Spans Wholesale And Retail Outlets
The FSDA orders had revoked licences belonging to 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 the Chamarajpet outlet of Bangalore Speciality Pharma.
Licences suspended by the authority included those held by Med Pharma, Surya Speciality Hospital, Sagar Pharma (Unit-II), Vivantha Pharmaceuticals, Maruthi Medicals, Viva Pharma in Belagavi, Hi-5 Pharma, and Pfizer.
Raids At Farmhouses Unearthed Counterfeit Network
The administrative crackdown originated from coordinated raids conducted on Aug. 18 at farmhouses situated in the Bidadi and Dodderi areas of Bengaluru South district. During the operation, enforcement teams confiscated suspected counterfeit drugs valued at approximately Rs 5 crore, alongside forged billing receipts, injection-filling equipment, and fake packaging labels. Following the haul, a Special Investigation Team was established to investigate the broader distribution network.
According to FSDA findings, the farmhouse facilities served as illicit repackaging centres where inexpensive medications sourced from neighbouring states were decanted into new glass vials. These cheaper drugs were then relabelled to counterfeit high-cost, life-saving therapies produced by multinational firms, focusing in particular on imitating imported products under the Pfizer brand.
The agency stated that the seized packaging featured counterfeit QR verification codes that proved non-functional upon scanning. Regulators warned that the counterfeit preparations lacked active pharmaceutical ingredients and posed potential health risks through the presence of harmful adulterants.
Details Of Confiscated Stock And Machinery
Enforcement officials recovered a wide range of forged pharmaceuticals during the August raid. The single largest component comprised 5,640 vials of counterfeit Cefiavigent 2.5 injections carrying spurious branding of Eucratia Healthcare Pvt Ltd, with an estimated market value exceeding Rs 3.38 crore.
Authorities also seized 1,531 vials of Hizlam injectables falsely attributed to Welcure Remedies, valued at Rs 52.24 lakh, and 264 vials of Emblaveo counterfeiting Pfizer products, worth Rs 20.59 lakh. Additionally, inspectors uncovered 30 boxes of expired medications valued at Rs 35 lakh, which investigators indicated were being prepared for reintroduction into commercial distribution.
The raid also yielded several other counterfeit injectable batches—including Xavitaz, Zavicefta, Tigynt, Tigvnet, Aztreo, and Trezam—as well as packaging materials, an automated injection-filling machine, and substantial quantities of forged seals and labels.
