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Generic drugs manufactured by Ranbaxy Labs banned in India over safety issues

NEWS: Generic drugs manufactured by Ranbaxy Labs banned in India over safety Issues, Attorney Claudine Homolash comments

Ed Silverman
Pharmalot.com, Pharmaceutical Industry News

2013-05-29 –

In the wake of the manufacturing scandal that led to a $500 million settlement between Ranbaxy Laboratories and the US Department of Justice, a hospital in Mumbai, India, has notified its staff not to purchase any medicines made by the generic drugmaker, The Times of India writes. (NOTE: see link below for 30 of the Ranbaxy generic drugs below.)

“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,” one doctor at Jaslok Hospital tells the paper. Another physician adds that, “normally, one doesn’t see an individual hospital taking such a stand. But it’s not a bad thing. Moreover, the management note is more of a general caution.”

Attorney Claudine Homolash: “The list of 30 drugs banned in the U.S. includes major products, such as the generic forms of Aricept, Tricor, Prozax, Lasix, Ativan, Toprol XL, Valtrex, Actos – to name a few. Many consumers may still be taking these banned drugs and don’t even know of the problems associated with them. Moreover, it is inexcusable that the FDA (and consumers and doctors who rely on the FDA) does not know whether a drug is safe and effective if it’s manufactured outside of the U.S.”

Hospital officials declined to explain their reasons for the ban, which was posted at a reception desk, although the paper adds that a meeting with Ranbaxy personnel was to have been held yesterday. We asked Ranbaxy for comment and will update you accordingly.

This is only the latest fallout from the manufacturing troubles that have roiled Ranbaxy for the past few years. After announcing the settlement, which included criminal and civil charges, India’s Ministry of Health & Family Welfare is considering action and asked the Drug Controller General of India to examine US court documents for signs that Ranbaxy similarly attempted to dupe domestic consumers.

Simiarly, the Indian Medical Association has also asked the DCGI to investigate Ranbaxy drugs. “We will soon be writing to the DCGI asking them to check and investigate if Ranbaxy drugs are of poor quality,” Narendra Saini, secretary general of the IMA, tells The Economic Times. “However, we will continue to prescribe the drugs to our patients, until the investigation proves that the drugs are of poor quality.”

As you may recall, for nearly a decade, Ranbaxy perpetuated a scheme to boost profits and maintain its edge as a leading purveyor of low-cost generics to the world. Scientists were ordered to manipulate data, other employees were forced to illegally carry supplies of brand-name drugs to India and duplicitous statements were issued by high-ranking executives (back stories here and here).

Five years before the settlement was reached, the FDA banned 30 Ranbaxy drugs from the US and imposed a consent decree with the drugmaker (see this). The settlement, however, does not include a Corporate Integrity Agreement, which would require Ranbaxy to establish procedures and accountability to avoid a repeat.

As a result, the feds could move to exclude the drugmaker from participating in contracts with Medicare and Medicaid, among other government healthcare programs. Although there is no indication such a step will be taken, Ranbaxy is reportedly considering eliminating up to one-third of its global team of sales reps, which currently numbers more than 14,000 people (look here).

Meanwhile, Daiichi Sankyo, which spent $4.6 billion to buy Ranbaxy several years ago, last week issued a curt statement saying legal action may be brought against the Singh family, which founded and controlled the drugmaker until selling its holdings. Former Ranbaxy CEO Malvinder Singh replied publicly by accusing Daiichi of failing to perform proper due diligence and trying to shift blame for the problems (read this).

For Ranbaxy Generic Drugs sold in the U.S. as reported by CNN Money/Fortune (look here).

Links

NEWS: Indian Hospital Bans Ranbaxy Drugs as Docs Question Safety, Pharmalot.com, May 29, 2013

 

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