Karnataka FDA cancels 16 licences in raid over alleged fake drug repackaging

Karnataka FDA cancelled sixteen drug licenses and suspended eight others. This action followed a raid on an unlicensed pharmaceutical repacking operation. Spurious medicines and machinery worth over five crore rupees were seized. A special investigation team is tracing the alleged supply chain network. Consumers are advised to buy medicines from licensed pharmacies only.

Karnataka’s Food Safety and Drug Administration (FDA) has uncovered an alleged unlicensed pharmaceutical repacking and relabelling operation at a farmhouse in Bidadi, with spurious drugs, machinery and printing material worth about Rs 5.05 crore seized during a raid on August 18.The department, which is conducting a series of raids on orders from new Health & Family Welfare Minister UT Khader, has also initiated action against retailers and wholesalers allegedly linked to the distribution and sale of spurious drugs. The licences of 16 entities have been cancelled and those of eight others suspended, according to an FDA statement.The licence of Pfizer C&F Depot at Kempalinganahalli in Nelamangala taluk, Bengaluru Rural district, also figures among the licenses suspended.The FDA's Drug Enforcement Wing conducted the joint inspection following a tip-off at a farmhouse in Kurubarakeranahalli in Bengaluru South district.Preliminary findings suggest the premises were allegedly used to procure low-cost medicines from neighbouring states, repackage them and relabel them as expensive life-saving drugs. The products allegedly carried labels imitating imported products under the Pfizer brand.The FDA said the counterfeit labels included QR and scanning codes that were non-functional when checked. The seized stock is undergoing laboratory analysis to establish its chemical composition, potency and sterility.The operation has raised concerns over the risks posed by unlicensed drug repacking and counterfeit medicines, particularly when products are presented as branded or life-saving drugs. Under the Drugs and Cosmetics Act, 1940, a drug is spurious if it is an imitation or substitute for another drug, resembles another drug in a manner likely to deceive, or purports to be a manufacturer's product when it is not.The department has registered a criminal case under the Act and is investigating the alleged supply chain. The seized drugs, machinery and printing material will be produced before the jurisdictional JMFC court for further proceedings, according to the FDA statement.The FDA also found 30 boxes of expired medicines at the premises, raising concerns that expired products could have been reintroduced into the supply chain.As part of the investigation, batch numbers and other details of the seized medicines are being blocked on the Karnataka FDA portal to prevent their further sale or distribution. Samples have been sent for testing.The Drugs and Cosmetics Act provides stringent penalties for offences involving spurious drugs, with punishment depending on the nature of the offence and the relevant provision invoked.The FDA has advised consumers to buy medicines only from licensed pharmacies and obtain valid invoices. It has also urged patients and consumers to report suspicious packaging, unusual labelling or non-functional QR codes to drug enforcement authorities.