The Can of Worms at Ranbaxy

[diga]

I read this recently... horrific. Have to be careful while buying any generics. Its quite a long read & I suggest everyone to read it.

But in Gurgaon, as Thakur's project managers gathered data and interviewed company scientists and executives, he says, they stumbled onto Ranbaxy's open secret: The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. "This was not something that was concealed," Thakur says. It was "common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people." Lying to regulators and backdating and forgery were commonplace, he says. The company even forged its own standard operating procedures, which FDA inspectors rely on to assess whether a company is following its own policies. Thakur's team was told of one instance in which company officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a "steam room" overnight to fool regulators.

Investigation by Fortune Cant understand why the govt is silent on this whole issue. Its as though, the govt knows it will open itself to patent & IPR scrutiny if it comments on Ranbaxy

[urbestfriend]

Terrible..! If this has been done to the drugs exported, no doubt drugs sold locally would be sub standard. Government is almost sleeping about this and I dont understand why media is also silent.

[urbestfriend]

Credit to Dinesh Thakur for blowing whistle :hatsoff: But dont understand why Singhs of Ranbaxy cant be sent to jail, this is serious offense.

[urbestfriend]

But inside the company, as events would make clear in the following months, the executives had decided against disclosing any further problems. (In an e-mail, Vimta's technical director, Harriman Vungal, says the studies it performed for Ranbaxy were "carried out as required" and "were not intended for submission outside India. Ranbaxy, on its own, had submitted to other countries and Vimta was unaware of what was submitted to WHO or others.")

Disgusting..

[diga]

Jaslok Hospital ,Mumbai advises doctors against prescribing Ranbaxy drugs

A Mumbai hospital has put up a notice advising its doctors to avoid prescribing drugs manufactured by Ranbaxy Laboratories. This comes a fortnight after Ranbaxy Laboratories agreed to pay a $500-million penalty to US authorities for "selling adulterated drugs" in the American market. It is not known whether the two are linked. Consultants at Jaslok Hospital said an advisory was put up at the receptionist's circular desk four days ago. "The notice doesn't give any reason, but merely states that Ranbaxy medicines won't be available at the hospital and doctors should, as far as possible, not prescribe these drugs," said a senior doctor who consults at Jaslok. Ranbaxy is one of the biggest drug manufacturers in the country, having made a name for itself by producing generics. However, in 2008-09, the US Food and Drug Administration found the company had not followed adequate rules in manufacturing drugs meant for the American market. This resulted in a ban of around 30 Ranbaxy drugs. Altaf Patel, also a consultant at Jaslok, said, "I believe the drugs that are under the US FDA scanner are anti-cancer ones. I don't need to prescribe those drugs in my practice. I have seen the efficacy of Ranbaxy drugs and I will prescribe them if needed. But it is good for hospitals to issue such cautions." A senior doctor said the only take-home lesson from the Ranbaxy fiasco for the Indian consumer was that drug companies have separate manufacturing facilities for local and export markets. "Why should Indian consumers be treated differently?" he asked.

[bulbul]

Dinesh Thakur and many others like him took advantage of the US culture and laws that honour and reward whistleblowers. Dinesh Thakur is yet to enter the National Whistleblowers Center Hall of Fame - or any other scroll of honour for that matter. His exploit, or expose, is too new and too fresh. Wikipedia records only one Dinesh Thakur, the Hindi film and theater artist who passed away last year. Facebook has a bunch of Dinesh Thakurs, but none from Belle Mead, New Jersey, where this one lives. He has just begun a Twitter feed with three tweets and 29 followers (as of Thursday night), one of which refers to his spare, new website and a statement he issued after he made a splash in the world media last week. He's kept a low, low profile. For this column, through his associates, he declined to be interviewed directly, while pointing to sources of authentic information amid a thicket of speculation and hearsay. In fact, it's a surprise he's even around digitally - most US whistleblowers disappear into a witness protection programme, wearing wig and dark glasses.

http://blogs.timesofindia.indiatimes.com/ruminations/entry/wind-behind-their-back

[diga]

Wockhardt too banned ...

The U.S. Food and Drug Administration slapped an import ban on Indian drugmaker Wockhardt Ltd. (532300.BY) after one of the company's plants failed an FDA safety inspection. The import ban only applies to drugs from one of Wockhardt's factories in Aurangabad, in the western Indian state of Maharashtra. The FDA issued an "import alert" Wednesday on medicines manufactured at the plant, which requires that any drugs sent from this plant be impounded by U.S. customs. The ban could lead to a revenue loss of $100 million for the company this fiscal year, Wockhardt Chairman Habil Khorakiwala told reporters on a conference call. "We are in the process of implementing corrective measures to be in compliance with the FDA guidelines," said Mr. Khorakiwala. He declined to say what medicines are produced at the factory. Wockhardt will continue to export medicines from its other 13 manufacturing facilities world-wide, he said. The import ban comes 10 days after Indian pharmaceutical company Ranbaxy Laboratories Ltd. (500359.BY) agreed to pay $500 million in civil and criminal fines for exporting adulterated drugs to the U.S. Mr. Khorakiwala said it will take a few months before Wockhardt can approach the U.S. regulator to have the ban lifted. Wockhardt has a second plant in Aurangabad that will produce the same set of drugs as the one on which the ban was placed, said Mr Khorakiwala. Wockhardt is awaiting regulatory clearance from the U.S. for the second factory before production can begin. It will then take six to nine months before the company recovers the revenue losses from the import ban, Mr. Khorakiwala added. Wockhardt earned 25.60 billion rupees ($460.6 million) for the year ended March 31, 2012. The financial results for last fiscal year haven't yet been released. Wockhardt's shares fell 20% on the Bombay Stock Exchange on the news of the import ban. They closed at 1,315.25 rupees on the Sensex, which was down 1.93%.

[flamy]

Haha, the media cares more about Dhoni's smile than this. When asking friends in India, the general consensus seems to be what a bad hit on rep Ranbaxy took and how sales will be affected. What? What about the fact that they are playing with people's lives? This is how Indian psyche works.