FDA action on Ranbaxy: Whistleblower says Indian pharma relies on jugaad

The US FDA while stopping imports from Ranbaxy’s Toansa plant has listed various faults it found with the plant, but according to a former whistleblower against the Indian pharmaceutical company there is a lot wrong with the industry that no one has taken the effort to correct.

In an interview to The Economic Times today, Dinesh Thakur, who famously blew the whistle over the company’s manufacturing practices earlier, argues the pharmaceutical industry in India has had a disinterested attitude in adhering to the standards set by the US FDA.

Thakur blames a culture in the Indian pharmaceutical industry that rewards short cuts, run by a close knit set of professionals and he questions why all shortcomings found in the Indian pharmaceutical companies are dismissed as documentation issues. According to him, relying on criticism of the US FDA won’t help in every case.

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[caption id=“attachment_1360615” align=“alignleft” width=“380”]  Representational image. Getty Images[/caption]

The former Ranbaxy executive blames the lack of data from the Indian pharmaceutical industry for the inability for drug regulators to know how safe drugs manufactured here and make fact based decisions.

“I have argued that our propensity for jugaad (quick-fix solutions) comes in the way of us developing quality systems and products. Public conversation after Ranbaxy pleaded guilty to felony charges last May was hijacked by talking heads who argued that the violations at Ranbaxy were nothing more than paperwork,” Thakur said in an interview to the Hindu Business Line.

Among the irregularities the US FDA has listed at Ranbaxy's Toansa plant include thepresence of flies in samplestorage room, uncalibrated instruments in laboratory andnon-adherence to sample analysis procedures. The US FDA has issued 48 import alerts against Indian pharmaceutical companies so far.

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While Ranbaxy's shares plummeted following news of the US FDA’s decision, the Drug Controller General of India has said that they wouldn’t go purely by the US FDA’s findings and would institute their own probe into the matter.

“…it must be stated that every country has different measures and we cannot judge Ranbaxy by standards set up by the American drug regulator. My job is to ensure there is no compromise on safety and efficacy on drugs and I am doing that,” GN Singh told Livemint.

While the Drug Controller General probes the FDA’s allegations, the Indian Medical Association has said it will be seeking advice from the regulator on whether its practitioners can continue prescribing medicines manufactured by the company.