Opposition MP Sylvia Lim of Aljunied GRC will be raising safety concerns in Parliament tomorrow (11 Nov) with regard to generic drugs used in Singapore, produced by India’s pharmaceutical giant Ranbaxy Laboratories Ltd.

Specifically, Ms Lim is asking Health Minister Gan Kim Yong:

To ask the Minister for Health in view of a subsidiary of the multinational pharmaceutical company Ranbaxy Laboratories Ltd being found guilty of data fraud by the US Food and Drug Administration in May 2013:

(a) whether the Health Sciences Authority (HSA) has done a review of all data submitted to it by Ranbaxy; and

(b) how HSA ensures Singapore’s supply of generic drugs from overseas is safe for use.

Ranbaxy operates in 43 countries with 21 manufacturing facilities spread across 8 countries. It develops many of the generic drugs in areas include: anti-infectives, cardiovascular, pain management, central nervous system, gastrointestinal, respiratory, dermatology, orthopaedics, nutritionals and urology. According to its website [Link], its R&D centres are located at Gurgaon, a city in the Indian state of Haryana.

In fact, one of the common generic anti-cholesterol drugs dispensed by SGH to Singaporeans here is Rovacor, produced by Ranbaxy:

Rovacor (generic Lovastatin) produced by Ranbaxy is commonly dispensed by Heart Centre of SGH to Singaporeans with cholesterol problems.

In May this year, Ranbaxy pleaded guilty to felony charges related to drug safety and paid a total of US$500 million in civil and criminal fines in the US [Link]. The settlement is the largest-ever with a generic drugmaker over drug safety, according to the US government. The settlement followed investigation by the Food and Drug Administration (FDA) into Ranbaxy’s poor manufacturing practices and falsifying data.

Ranbaxy pleaded guilty to 3 felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to 4 counts of making material false statements to FDA.

A spokesperson from the US Department of Justice said in a statement, “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.”

“We will continue to work with our law enforcement partners to ensure that all manufacturers of drugs approved by the FDA for sale in the United States, both domestic and foreign, follow the FDA guidelines that protect all of us.”

Another US official added, “The joint criminal and civil settlement, which reflects many years of work by FDA agents and federal prosecutors, holds Ranbaxy accountable for a pattern of violations and should improve the reliability of generic drugs manufactured in India by Ranbaxy.”

In 2008, the FDA banned Ranbaxy from selling about 30 drugs in the US after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India.

Ranbaxy then stopped selling drugs to the US market while it fixed problems with its manufacturing procedures in the US and India.

The fraudulent practices came to light when an ex-employee, Dinesh Thakur, whistleblew on the company [Link].

“It took us eight years to help government authorities unravel a complicated trail of falsified records and dangerous manufacturing practices that threatened to compromise the quality and safety of Ranbaxy drugs,” he said.

In a media interview, he described how Ranbaxy had typically falsified data, “When you find a blood sample rework for one patient copied 23 times because there are 24 patients needed to prove bioequivalence, that’s not an error (in Ranbaxy).”

Elaborating how the company’s drug failed to provide relief, Thankur said, “The expectations is the drug is supposed to work as intended… What we saw in this particular case is that trust was broken.”

Recounting an incident where his son was prescribed a Ranbaxy antibiotic for a fever, Thakur said, “He (son) kept getting worse, so we got another company’s formulation and the fever went away.”

The company has since grappled with other manufacturing problems. In Nov last year, it recalled some generic Lipitor, known as atorvastatin, in the US after certain batches were found to contain glass particles. It has since resumed manufacturing the widely used cholesterol lowering medicine.

It’s not known if Singaporeans have been consuming sub-standard drugs from Ranbaxy in all these years. Perhaps Minister Gan can shed some lights in the Parliamentary sitting tomorrow.


TR Emeritus

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