Industry Odisha Bureau, Sep 23: Pfizer India has responded to a Karnataka FDA crackdown on alleged counterfeit drugs. The regulator cancelled 16 licences and suspended eight others. Pfizer said patient safety remains its top priority throughout the investigation.
Karnataka FDA Escalates Counterfeit Drug Enforcement
Karnataka’s drug regulator has widened its enforcement against alleged spurious medicines. Authorities cancelled 16 drug licences held by retailers and wholesalers. Eight additional licences were suspended pending further scrutiny. The action followed allegations of distributing and selling spurious medicines. Officials have not named individual licence holders publicly. The Karnataka Food and Drug Administration linked the licences to an ongoing counterfeit-medicine investigation.
Pfizer Pulls Batches After Numbers Allegedly Copied
Pfizer India said patient safety and product quality remain its highest priorities. The company said counterfeiters allegedly copied numbers from genuine Pfizer batches. It therefore withdrew those specific batches from the market. Pfizer said this step aimed to prevent confusion for patients. The company did not describe these batches as defective or unsafe. Pfizer said it had engaged with authorities for about a month.
August Raid Uncovers Alleged Repacking Operation
The enforcement action traces back to an August 18 inspection. Karnataka FDA’s drug-enforcement wing conducted the raid that day. Officials allegedly discovered an unlicensed repacking and relabelling operation. The site was a farmhouse in Kurubarakerenahalli, Bidadi. That location falls within Bengaluru South district.
Medicines Allegedly Relabelled as Costlier Products
A preliminary investigation examined medicines allegedly sourced from neighbouring states. Officials alleged these were repacked into new vials. They were then allegedly relabelled as expensive life-saving medicines. Products purportedly carrying Pfizer branding were among those identified. Authorities have not confirmed the full scale of distribution.
Seized Materials Valued Around Rs 5.05 Crore
Officials reported seizing spurious drugs, machinery and printing materials. These items were valued at around Rs 5.05 crore. The figure reflects seized-material value, not confirmed sales or losses.
Pfizer Supports Product Authentication Efforts
Pfizer said it supplied technical information about the affected batches. The company said it supported efforts to distinguish genuine products from counterfeits. Pfizer said this cooperation with authorities continues on open queries. It framed its involvement around protecting patients and public confidence.
Criminal Case Registered Under Drug Law
Authorities have registered a criminal case under the Drugs and Cosmetics Act, 1940. No arrests, charges or prosecution outcomes have been disclosed. The investigation into the alleged counterfeit-medicine network remains ongoing. Karnataka FDA has not indicated a timeline for its conclusion. The episode highlights continuing enforcement pressure on India’s pharmaceutical supply chain, particularly around drug licences, batch authentication and counterfeit medicines involving multinational brands.
