Tagged Articles

India 15 articles

Montgomery, Ala., whistleblower files second retaliation lawsuit against Infosys  

MONTGOMERY, Ala. — A Montgomery, Ala., man who sued his Bangalore, India-based employer, Infosys, in 2011, alleging he suffered through harassment, isolation, abuse, and even death threats after he blew the whistle on the company’s fraudulent visa practices, has filed a new wrongful termination lawsuit seeking compensation and reinstatement to his job. Jack Palmer, a former software project manager for Infosys, filed his first lawsuit against the company in 2011. In that suit, Mr. Palmer claimed that he suffered harassment and other forms of harsh backlash after he complained of the company’s visa practices through the proper internal channels. Specifically, ... Read More

FDA stands by decision to ban import of drugs from Ranbaxy’s India plant

Ranbaxy Laboratories Inc.’s drugs manufactured at its plant in India were banned from entering the United States by the Food and Drug Administration (FDA) due to quality concerns, but European regulators say the plant does not pose a risk to public health. The FDA’s ban came after the agency in January announced it had uncovered drug safety violations at the pharmaceutical company’s India plant. FDA investigators found that employees at the plant had re-tested some of the drugs to gain more favorable results after the drugs failed initial tests. They also found that the facility lacked appropriate controls over computerized ... Read More

FDA creates new unit to address quality concerns with drugs made overseas

Concerns about drug quality have prompted the Food and Drug Administration (FDA) to create a new unit in order to improve the agency’s scrutiny of overseas drug manufacturing plants producing brand-name, generic and over-the-counter drugs of questionable quality. The Office of Pharmaceutical Quality aims to work with drug makers to develop data that can help identify which manufacturing plants are falling below standards and need closer and more frequent inspection. Such information is currently only collected during regular inspections. The goal is to head off any issues that would result in penalties, such as banning a product for sale in the United ... Read More

Generic drug maker settles whistleblower case for $500 million

MONTGOMERY, Ala.—The Alabama Attorney General’s office announced Tuesday that it participated with other states and the federal government in a $500-million settlement with India-based generic drug manufacturer Ranbaxy to resolve civil and criminal allegations that company for years made and sold dozens of adulterated prescription drugs. The company’s willful manufacture of 26 generic prescription drugs below the U.S. Food and Drug Administration’s (FDA) standards for strength, purity, and quality resulted in fraudulent claims submitted to Alabama’s Medicaid Agency as well as other state and federal health care programs. “This settlement sends a strong message to international drug manufacturers that they ... Read More

Judge considers consolidating Actos lawsuits

Judges are considering whether to consolidate tens of thousands of lawsuits filed in the United States against Japanese drug maker Takeda over its type 2 diabetes drug Actos. The lawsuits claim the drug causes bladder cancer. The claims are backed up by an alert issued by the Food and Drug Administration (FDA) earlier this year which warned that studies linked Actos to bladder cancer, and that the risk was even greater in patients who used the drug for more than a year. Actos sales grew considerably early last year after the FDA severely restricted the sale of the type 2 ... Read More

Actos maker hopes to push diabetes drug in China

Japan’s Takeda Pharmaceutical Co., is reading the writing on the wall, and looking for other money-making opportunities outside its home and the United States. The move is an attempt for Takeda to stabilize its finances in anticipation of a decline in sales of its best-selling diabetes treatment Actos. Not only does Actos face generic competition in August, it is also under review by the Food and Drug Administration (FDA) based on studies that show the drug puts users at risk for bladder cancer. Japan’s biggest pharmaceutical company is actively looking at acquisitions or joint ventures in India and to invest ... Read More

India a testing ground for Gardasil and other drugs

A report by New America Media recently shined a spotlight on the practice of drug testing in countries such as Russia, China, Brazil, Romania and India. Drug companies have found these countries offer a large population of indigent, poor and illiterate people who are willing to participate in drug trials in return for financial compensation. The practice is booming in India, reports Zeina Awad, a health reporter for Al Jazeeera’s “Fault Lines” program. Awad traveled to India to explore the practice of clinical research being conducted there, and to examine what role, if any, United States regulatory agencies play in ... Read More

France, UK cracking down on advertising for HPV vaccines

Government health agencies in France and the United Kingdom are cracking down on the manufacturers of HPV vaccines Gardasil and Cervarix, saying the companies are falsely advertising their products. According to a report in the American Chronicle, vaccine watchdog organization SANE VAX has been following the investigation of problems with the advertisements, which have resulted in the ads being banned in France and removed in the UK and India. Although not reported in most mainstream media, SANE VAX discovered the French government had banned Gardasil ads in August 2010. The drug, which targets and prevents four types of human papillomavirus ... Read More

FDA knew of tainted syringes two years before inspecting plant

The FDA received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press. AM2PAT is now the subject of a criminal investigation. Federal investigators say the company was so focused on making profits that it did not conduct necessary safety tests and instead covered up the matter by falsifying reports to make it appear those tests had been conducted. Earlier this week, workers ... Read More

Lawmakers call for rule requiring drugs be made in U.S.

Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.” Such is the case with the blood thinner heparin, which last year was the focus of much scrutiny when 80 Americans died and hundreds more were sickened after receiving doses of heparin manufactured ... Read More