Pharma fraud: Will Ranbaxy reassure us?

Company pays huge fine in the US for adulterated drugs, focus on home market regulations now

ashishm

Ashish Mehta | May 14, 2013



Our home-grown pharma giant Ranbaxy Laboratories has been slapped a $500 million fine in the US for selling adulterated drugs. The three drugs in question were manufactured at two plants in India. The adulterated stuff could enter the US market hoodwinking food and drug administration (FDA) hawks. Now the US department of justice (DoJ) has done its job, and the American consumers can feel reassured but what about their Indian counterparts?

All that Arun Sawhney, chief executive of Ranbaxy, had to say in a statement was this: "While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy's stakeholders. … The conclusion of the DOJ investigation does not materially impact our current financial situation or performance," he added.

Ranbaxy has thus chosen to reassure its shareholders, don’t worry, the company is doing fine. Whether the patients taking Ranbaxy drugs should worry or not is not clear. There is no apology, no reassurance.

Reassurance has to come also from our equivalent of FDA, the Central Drugs Standard Control Organization, on our regulatory practices. Dinesh Thakur, the whistleblower who worked as director of project and information management with Ranbaxy, has said in a statement, “As a senior pharmaceutical executive, I understand the importance of regulatory oversight in ensuring drug quality and safety. … This case highlights the need for effective regulation that applies to drugs sold in the United States, regardless where they are manufactured.” It also highlights the need for effective regulation in India, regardless where they are imported.

The company has to be more forthcoming in its reassurances, because Thakur has said that, "Ranbaxy's management was notified of these widespread problems. When they failed to correct the problems, it left me with no choice but to alert healthcare authorities."

Because lives could be at stake. The US court used quite strong words to admonish the firm. Stuart F. Delery, acting assistant attorney general for the Civil Division of the Justice Department, said, "When companies sell adulterated drugs, they undermine the integrity of the FDA's approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe."

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