Medicines Made in India May Not be Safe According to FDA
India is coming under scrutiny by U.S. regulators due to potential safety lapses, falsified drug tests, and the selling of fake medications. India is the second largest exporter of over the counter and prescription drugs, supplying approximately 40 percent of over the counter and prescription drugs in the U.S.
Dr. Margaret Hamburg arrived in India this week due to growing unease with “recent lapses in quality at a handful of pharmaceutical firms.”
The FDA recently de-certified one of the most recent approved factories operated by one of India’s largest drug producer. They are also banning the sales of many drugs that do not meet U.S. standards. This mostly applies to some generic copies of brand name drugs.
During Dr. Hamburg’s visit, Indian business leaders brought up the long approval period for new drugs about which Dr. Hamburg stated, “I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality. In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly.”
FDA investigators are scrutinizing Indian drug plants utilizing some of the estimated $300 million in annual fees collected as a part of the law requiring the supervision of plants that are located overseas.
The FDA inspected 160 plants last year, roughly three times as many as in 2009.
“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those,” stated ,” G. N. Singh, India’s top drug regulator.
Medicines Made in India May Not be Safe According to FDA.