Suspended Reviews Of New Products From Ranbaxy

Serious safety concerns have been raised over India’s generic drugs industry after US regulators said that they would no longer approve products produced at a factory run by the country’s largest maker of medicines.

The US Food and Drug Administration (FDA) said that it had suspended reviews of new products from Ranbaxy’s plant in Paonta Sahib, in northern India, after uncovering “significant questions about the reliability” of information used to support requests to sell drugs in the US.

Shares in Daiichi Sankyo, the Japanese company that bought a majority stake in Ranbaxy for more than $4 billion last year, fell by almost 10 per cent in Tokyo. Ranbaxy plummeted as much as 18 per cent in Mumbai.

Investors fear that the FDA decision could have serious knock-on consequences for the generic version of the world’s most lucrative drug. Ranbaxy holds the right to distribute the first copies of Lipitor, the cholesterol pill developed by Pfizer, which achieved sales of $12.7 billion in 2007.

The Indian company has been the focus of FDA scrutiny for several years. Last year, the watchdog claimed it had evidence to suggest that Ranbaxy used active pharmaceutical ingredients from unapproved sources, resulting in the sale of "subpotent, super potent or adulterated medicines" in the US. It is alleged that test data was fabricated to show that medicines met FDA standards.

In September, it banned Ranbaxy from importing more than 30 generic drugs into the US due to serious manufacturing violations it cited at two company plants in India, including Paonta Sahib.

Researchers for HIV work

Even as Connecticut considers reducing funding for AIDS programs, state public health researchers are winning accolades for their work with those living with HIV.

A program developed at the University of Connecticut's Center for Health, Intervention and Prevention is among a group of eight intervention programs commended recently by the U.S. Centers for Disease Control and Prevention.

Under the program, known as "Options," clinicians are trained to counsel HIV-positive patients during routine medical appointments to avoid risky behavior, such as unprotected sex and drug use, developing a list of behavioral prescriptions for patients to follow as they live with the virus.

"Most interventions focus on people not infected with HIV and not likely to become infected," said Jeffrey D. Fisher, a social psychology professor at UConn and director of the intervention center. "But we also need to help people who have HIV to practice safer sex and drug use."

Such precautions are necessary not just to protect the health of those living with HIV or AIDS, which make patients substantially more susceptible to infection and disease, but also to ensure that continued risky behavior doesn't spread HIV to those with whom diagnosed people share needles or have sex.

Fisher developed the program in the late 1990s with his brother, Bill Fisher, a professor at the University of Western Ontario, and three other researchers from CHIP and Yale University.

The Options program was developed from current behavioral theory and a process of collaboration with those struggling with HIV diagnosis and problems with substance abuse or risky sex, Fisher said. The intervention plan asks clinical workers to work with patients to develop strategies for reducing risk, and to evaluate each patient's willingness to change.

The program was included this year in "The 2008 Compendium of Evidence-based HIV Prevention Interventions," which is compiled annually by the CDC, and recognizes programs that have proven successful at reducing HIV infection and behavior that can increase the chance of contracting sexually transmitted diseases.

The CDC estimates that 46,000 people were infected with HIV in the U.S. in 2006, the most recent year for which data was available.

Source: theday.com/re.aspx?re=76b88ed9-71a3-4510-a675-6361d367da02

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