Pfizer India says patient safety is top priority after Karnataka FDA cancels 16 drug licenses in counterfeit crackdown

Pfizer India's response to the Karnataka FDA action

Pfizer India said on Tuesday evening that "patient safety and product quality are of the highest priority for us at Pfizer," reacting to the Karnataka Food and Drug Administration's move against the alleged circulation of counterfeit medicines. The company said it had been working with authorities for roughly a month since the matter was brought to its attention and had taken several steps to support the investigation, including withdrawing from circulation Pfizer batches whose numbers had been copied by counterfeiters to avoid confusion, helping distinguish original from counterfeit product, and providing technical information about the affected batches. Pfizer added that it continues to work closely with authorities to resolve open queries and that its focus remains on protecting patients and safeguarding public health.

What the Karnataka FDA did and what investigators say they found

The Karnataka health regulator said on Sunday that it canceled 16 drug licenses of retailers and wholesalers and suspended eight others in connection with the alleged distribution and sale of spurious medicines. The action followed an inspection by the FDA's drug-enforcement wing on August 18 at a farmhouse in Kurubarakeranahalli, Bidadi, in Bengaluru South district, where officials said they busted an unlicensed repacking-and-relabelling operation. Investigators alleged that low-cost medicines procured from neighboring states were re-packed in new vials and re-labeled as expensive life-saving medicines from multinational companies, including products purportedly bearing the "Pfizer" brand. Spurious drugs, machinery and printing materials valued at around ₹5.05 crore were seized during the raid, and a criminal case has been registered under the Drugs and Cosmetics Act, 1940.

Open questions around the investigation

The two reports do not specify the therapeutic categories of the counterfeited Pfizer batches, the number of batches removed from the Indian market, or the identities of the retailers and wholesalers whose licenses were canceled or suspended. It is also not stated whether any Pfizer employees or authorized distributors are alleged to have been involved. The two outlets converge on the core facts of the license action, the seized value and the company's stated response, but differ only in framing: one characterises the regulator's move as a "crackdown," while the other describes it more neutrally as an "action."

Next milestone

Karnataka FDA investigators are continuing to pursue the criminal case filed under the Drugs and Cosmetics Act, 1940, with Pfizer India stating it continues to work closely with authorities to resolve open queries arising from the raid.