Bengaluru: The Karnataka Food Safety and Drugs Administration (FDA) has uncovered an alleged unlicensed pharmaceutical repacking and relabelling operation at a farmhouse near Bidadi and seized drugs, machinery, labels and other materials estimated to be worth ₹4,91,49,575.
According to a press note issued by the Office of the Commissioner, Food Safety and Drugs Administration, the Drug Enforcement Wing acted on a tip-off on August 18 and inspected a facility at farmhouse No. 34, Kurubarakerenahalli, Bidadi, in Bengaluru South district.
The FDA said its preliminary investigation found that the premises was allegedly being used to procure lower-cost medicines from other states, fill them into new vials and relabel them to imitate expensive multinational corporation brands and imported drugs. The department specifically referred to Pfizer in its press note and said scanning codes on the labels used for the alleged operation were non-functional.
The department said the operation was being carried out without a licence and cited provisions of the Drugs and Cosmetics Act, 1940. According to the press note, spurious drugs are dealt with under Section 17B, while punishment for manufacturing, selling, stocking or distributing such drugs is provided under Section 27. The department said penalties can range from a minimum of 10 years’ imprisonment to life imprisonment. It added that the seized stock would be produced before the JMFC court in Bengaluru South.
The largest component of the seizure listed by the FDA was 5,640 vials labelled “CEFIAVIGENT 2.5 INJECTION”, with M/s Eucratia Healthcare Pvt. Ltd. shown as the manufacturer on the allegedly forged label. The stock was valued at ₹3,38,34,360.
Officials also seized 1,531 vials labelled “HIZLAM INJECTABLES”, carrying M/s Welcure Remedies as the listed manufacturer on the allegedly forged label, valued at ₹52,24,537. Thirty boxes of expired drugs were valued at ₹35 lakh.
Other seized products listed by the department included 470 vials of Xavitaz Injection valued at ₹27,49,500; 264 vials labelled EMBLAVEO, with M/s Pfizer Limited shown as the manufacturer on the allegedly forged label, valued at ₹20,59,200; and 165 vials of Zavicefta Injection valued at ₹5,45,490.
The inventory further listed 44 TIGYNT IV vials, with M/s Stanex Drugs & Chemicals shown as the manufacturer on the allegedly forged label, valued at ₹2,06,910; 44 Tigynet injections valued at ₹2,06,888; 190 vials of Aztreo Injection valued at ₹1,48,960; and 50 vials of Trezam Injection valued at ₹1 lakh.
The FDA also seized two boxes of packaging components, including stoppers and caps, valued at ₹75,000; one injection-filling machine valued at ₹5 lakh; and forged labels and stamps in bulk, valued at ₹2 lakh.
The department said the preliminary investigation had identified several alleged violations, including manufacture, storage and distribution of drugs without a licence. It said the alleged relabelling of generic or lower-cost drugs as premium brands raised concerns over the authenticity and safety of medicines reaching patients.
The FDA also flagged the recovery of 30 boxes of expired medicines, saying it suggested that expired drugs were being reintegrated into the supply chain and could pose a serious public health risk.
As part of regulatory action, the batch numbers and entries relating to the seized drugs are being blocked on the Karnataka FDA portal to prevent further distribution or sale, the department said.
Samples of the seized products have also been sent for laboratory testing to verify their chemical composition, sterility and potency.
The FDA said a police complaint has been lodged with Tavarekere Police Station. Law-enforcement and regulatory officials are working together to complete the investigation and initiate prosecution against those found responsible.
The press note does not identify the owner or occupant of the farmhouse or state whether any person has been arrested. The allegations regarding the seized products remain subject to laboratory verification and further investigation.
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