Patient safety top priority for us: Pfizer after Karnataka FDA action

Pfizer claimed that it has been working with authorities for the last one month since the matter was brought to its attention (Photo: Reuters)

Pfizer on Tuesday said patient safety and product quality are its highest priorities, reacting to the Karnataka Food and Drug Administration's (FDA) action regarding the circulation of counterfeit drugs.

The Karnataka health regulator on Sunday said it has cancelled 16 drug licences of retailers and wholesalers and suspended eight others in connection with the alleged distribution and sale of spurious medicines.

"Patient safety and product quality are of the highest priority for us at Pfizer," the company said in a statement late on Tuesday evening.

Pfizer claimed that it has been working with authorities for the last one month since the matter was brought to its attention.

"Since then, we have taken several actions to support the investigation, including removing from the market Pfizer batches (where batch numbers were copied by counterfeit) to avoid confusion, supporting to differentiate between original and counterfeit product, and providing technical and other relevant information related to the affected batches," the company added.

Pfizer stated that it continues to work closely with authorities to resolve the open queries, emphasising that its focus remains on protecting patients, safeguarding public health and maintaining confidence in the healthcare system.

The Karnataka FDA's action followed an inspection by its drug-enforcement wing on August 18, when an alleged unlicensed pharmaceutical repacking-and-relabelling operation was busted at a farmhouse in Kurubarakeranahalli, Bidadi, in Bengaluru South district.

Officials said spurious drugs, machinery and printing materials valued at around ₹5.05 crore were seized during the raid.

A preliminary investigation revealed that low-cost medicines procured from neighbouring states were allegedly repacked in new vials and re-labelled as expensive life-saving medicines from multinational companies, including products purportedly bearing the "Pfizer" brand, the FDA had said in a release.

A criminal case has been registered under the Drugs and Cosmetics Act, 1940.

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