 "Ranbaxy's decade long tryst with trouble")
Ranbaxy shares nose-dived 35% in early trade even as the Sensex zoomed 300 points after reports that the US Food and Drug Administration (USFDA) issued an import alert on the company’s Mohali unit. This is just the latest in a spate of run-ins the pharma major has had with the US regulator & other legal authorities in the last decade.
Here’s a detailed timeline of Ranbaxy’s unremitting tryst with trouble which started way back in 2004 –
2004
An inspection done by the WHO (World Health Organization) at Vimata Laboratories, a company hired by Ranbaxy to administer clinical tests on its AIDS drugs found the tests to be fabricated.
An inspection done by the WHO (World Health Organization) at Vimata Laboratories, a company hired by Ranbaxy to administer clinical tests on its AIDS drugs found the tests to be fabricated.
2004-07
Whistle-blower Dinesh Thakur working under Rajindar Kumar in the R&D wing of Ranbaxy undertook a series of investigations that unearthed routine irregularities and falification of data at Ranbaxy’s facilities. He quit in 2005, turned whistle-blower in 2007 and helped the US USFDA with its prolonged regulatory battle with the drug maker that ended with Ranbaxy pleading guilty of 7 counts of fraud early this year.
Whistle-blower Dinesh Thakur working under Rajindar Kumar in the R&D wing of Ranbaxy undertook a series of investigations that unearthed routine irregularities and falification of data at Ranbaxy’s facilities. He quit in 2005, turned whistle-blower in 2007 and helped the US USFDA with its prolonged regulatory battle with the drug maker that ended with Ranbaxy pleading guilty of 7 counts of fraud early this year.
2005
A patent ruling prohibits Ranbaxy from producing it’s own version of Pfizer’s anti-cholestoral drug Lipitor’s Atorvastatin. The dispute with Pfizer was eventually settled years later in 2008 allowing Ranbaxy to launch the generic version of the blockbuster drug from November 2011. This settlement also led to the resolution of Ranbaxy’s patent disputes with Pfizer in other countries.
A patent ruling prohibits Ranbaxy from producing it’s own version of Pfizer’s anti-cholestoral drug Lipitor’s Atorvastatin. The dispute with Pfizer was eventually settled years later in 2008 allowing Ranbaxy to launch the generic version of the blockbuster drug from November 2011. This settlement also led to the resolution of Ranbaxy’s patent disputes with Pfizer in other countries.
2006
In June 2006 the USFDA issued a warning letter to Ranbaxy citing violations of US cGMP (Current Good Manufacturing Practices) at its Paonta Sahib facility. This was in many ways to beginning of Ranbaxy’s continuing face-off with the US regulator.
In June 2006 the USFDA issued a warning letter to Ranbaxy citing violations of US cGMP (Current Good Manufacturing Practices) at its Paonta Sahib facility. This was in many ways to beginning of Ranbaxy’s continuing face-off with the US regulator.
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2008
In September 2008, in a 2nd warning in 3 years the USFDA announced it was restricting import of 30 drugs produced by Ranbaxy in Paonta Sahib and Dewas its facilities in Madhya Pradesh and Himachal Pradesh for not meeting standards.
In September 2008, in a 2nd warning in 3 years the USFDA announced it was restricting import of 30 drugs produced by Ranbaxy in Paonta Sahib and Dewas its facilities in Madhya Pradesh and Himachal Pradesh for not meeting standards.
2009
In early 2009 the FDA announced that it was invoking its Application Integrity Policy against Ranbaxy’s Paonta Sahib manufacturing facility. This meant the FDA would no longer have the burden of proving fraud in order to blocak a Ranbaxy product. “The onus had flipped, and now the company would have to prove its products weren't fraudulent in order to get them approved.”Katherine Eban author of Fortune Magazine’s exhaustive report ‘Dirty Medicine’ wrote. Within 3 months of the incident Malvinder stepped down as CEO.
In early 2009 the FDA announced that it was invoking its Application Integrity Policy against Ranbaxy’s Paonta Sahib manufacturing facility. This meant the FDA would no longer have the burden of proving fraud in order to blocak a Ranbaxy product. “The onus had flipped, and now the company would have to prove its products weren't fraudulent in order to get them approved.”Katherine Eban author of Fortune Magazine’s exhaustive report ‘Dirty Medicine’ wrote. Within 3 months of the incident Malvinder stepped down as CEO.
Later that year Ranbaxy’s wholly owned subsidiary Ohm Laboratories was sent a warning letter for certain cGMP violations at its facility located in Gloversville, New York.
2012
Even as the negotiations continued in January 2012, the US Justice Department filed a “ground breaking” consent decree to resolve issues over quality of Ranbaxy’s drugs and several regulatory issues. The decree required Ranbaxy to make fundamental changes in the way its plants operated globally.
Even as the negotiations continued in January 2012, the US Justice Department filed a “ground breaking” consent decree to resolve issues over quality of Ranbaxy’s drugs and several regulatory issues. The decree required Ranbaxy to make fundamental changes in the way its plants operated globally.
Later that year 2 other setbacks where Ranbaxy was hit by a recall of 3 batches of its Pantoprazole in the Netherlands owing to impurities and had to halt production and recall 41 lots of Astrovastatin because of glass particals in some bottles.
2013
The big blow came in May 2013 when Ranbaxy was fined $500 mn as it pleaded guilty on seven federal criminal counts including selling adultrated drugs, intention to defraud etc.
The big blow came in May 2013 when Ranbaxy was fined $500 mn as it pleaded guilty on seven federal criminal counts including selling adultrated drugs, intention to defraud etc.
But the trouble clearly doesn’t seem to end for Ranbaxy.
The new import alert has been slapped on it’s Mohali plant where most of the new drugs were slated to be manufactured. This has led to brokerages like HSBC downgrading Ranbaxy immediately to “underweight” from “overweight”. While there are no sales happening from Mohali and hence there will be no financial impact, HSBC believes “hopes for approvals for new products from Mohali have been dashed. We understand Ranbaxy had been working with the USFDA on approval of Diovan from Mohali."