In a major crackdown on counterfeit pharmaceuticals, the Karnataka Food Safety and Drug Administration (FSDA), Drugs Control Wing, has busted an alleged spurious drug manufacturing and repackaging operation near Bidadi on the outskirts of Bengaluru. The action followed a tip-off received by the police.

The raid was conducted at an unlicensed premises near Hejjala, close to the Bidadi toll gate in Ramanagara district. According to Karnataka FSDA officials, the facility, located at a farmhouse in Kurubarakeranahalli, Bidadi, Bengaluru South District, was allegedly being used to manufacture, relabel and package counterfeit medicines resembling products of leading multinational pharmaceutical companies.

The estimated market value of the seized medicines and related materials exceeds INR 5 crore.

Karnataka FSDA Commissioner K Srinivas, who led the operation along with Additional Drugs Controller Dr. Umesh S, said the seized drug batches and their corresponding entries have been blocked on the Karnataka FDA portal to prevent their further distribution or sale.

A police complaint has also been filed at the Tavarekere Police Station, while regulatory and law-enforcement authorities are continuing their investigation and preparing to initiate prosecution against those responsible.

Preliminary findings indicate that the premises was allegedly being used to procure lower-cost medicines from other states and subsequently fill or repackage them into new vials. These products were then allegedly relabelled to resemble expensive multinational brands and imported medicines, including products associated with Pfizer.

Officials also found that the scanning codes displayed on the labels were non-functional, raising further concerns about the authenticity and traceability of the products.

The raid resulted in the seizure of large quantities of finished suspected counterfeit medicine batches, counterfeit foils and packaging materials, labelling machinery, raw materials and blister-style packaging sheets. The premises reportedly did not possess valid licences for the manufacture, storage or handling of pharmaceutical products, constituting violations of statutory requirements under the Drugs and Cosmetics Act, 1940.

Under the Act, spurious drugs are covered under Section 17B, while offences relating to their manufacture, sale, stocking and distribution attract stringent penalties under Section 27. Depending on the nature and circumstances of the offence, penalties can include imprisonment ranging from a minimum of 10 years to life imprisonment. The seized stock is expected to be produced before the Judicial Magistrate First Class (JMFC) court in Bengaluru South.

Among the major seizures were 5,460 vials of Cefiavigent 2.5 injection, reportedly manufactured by Eucratia Healthcare, with an estimated value of INR 3.38 crore, and 1,531 vials of Hizlam injectable from Welcure Remedies, valued at approximately INR 52.24 lakh.

Officials also seized expired or otherwise suspect stocks, including 470 vials of Xavitaj injection, valued at approximately INR 27.49 lakh; 264 vials of Emblaveo, associated with Pfizer, valued at INR 20.59 lakh; and 165 vials of Zavicefta injection, valued at INR 5.45 lakh.

Other seized products included 44 vials of Tigynt IV, valued at INR 2.06 lakh; 44 vials of Tigvnet injections, valued at INR 2.06 lakh; 190 vials of Aztreao injection, valued at INR 1.48 lakh; and 50 vials of Trezam injection, valued at INR 1 lakh.

In addition to finished pharmaceutical products, authorities recovered packaging materials valued at approximately INR 75,000, an injection-filling machine valued at INR 5 lakh, and forged labels and stamps valued at approximately INR 2 lakh.

The Karnataka FDA has advised consumers to purchase medicines only from licensed pharmacies and to remain alert to suspicious packaging, labelling or product information. Consumers have also been urged to report suspected counterfeit or spurious medicines to the appropriate regulatory authorities.

The operation underscores the continuing regulatory focus on preventing the manufacture and distribution of spurious medicines, which can pose significant risks to patient safety while undermining the integrity of the pharmaceutical supply chain.