The U.S. Food and Drug Administration (FDA) has deemed India-made medicines unsafe, Health News Lines confirms.
Dr. Margaret Hamburg, commissioner of the FDA, raised the concern and claims that it was based on the numerous inspections that the health watchdog has carried out in India during the past couple of years.
Hamburg stressed the fact that India's reputation is being compromised due to some pharmaceutical companies that do not adhere to the requisite quality norms. However, at present, India is still regarded as the second largest exporter of over-the-counter and prescription drugs to the United States.
Ranbaxy, one of India's biggest drug manufacturers, had to pay $500 million last year after an inspection conducted by the FDA.
However, there have been recent discussions between the drug manufacturing company and the FDA to conduct workshops over different locations in India aimed at creating awareness among Indian pharmaceutical companies regarding the varying quality requirements in the U.S. market. The workshops are initially planned to be held next year and will be held at four different locations in India.
Experts who have expressed their thoughts about the issue believe that the FDA's action is justified and should continue.
"If there were no cops around, would everyone drive past the speed limit? You get careless, start taking risks," said Heather Bresch, chief executive of Mylan, a pharmaceutical company located in Pennsylvania.
On top of this, the FDA is also looking into pharmaceutical companies in China, although their attempts at carrying out surprise inspections have been thwarted by the Chinese government.
