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FDA Express Concerns over Medications made in India

Update Date: Feb 17, 2014 02:04 PM EST
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The United States Food and Drug Administration (FDA) has expressed concerns over the safety and quality of the drugs produced by Indian pharmaceutical companies. Upon returning from a trip to Indian, the FDA commissioner Dr. Margaret Hamburg stated that medicines made in India increase consumers' risk of illness, recalls and warnings related to drugs that they rely on daily.

"This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable," Hamburg said reported by FOX News.

Hamburg had met up with executives from the Indian pharmaceutical and food exporting companies. India is the U.S.'s second largest exporter of prescription and over-the-counter drugs. At the meeting, Hamburg had to reiterate the fact that the lapses in quality and safety are unacceptable. India's drug quality is still a huge concern and needs to be improved upon. As a way to mend this, the FDA is planning on creating an Office of Pharmaceutical Quality that would increase the agency's scrutiny over brand name, generic and over-the-counter medications.

"One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product," Hamburg said.

Back in 2013, the agency had investigated 160 Indian drug factories. Many of these drug plants received penalties and warning letters regarding their products. Hamburg stated that many of the Indian companies expressed concerns over the fact that the U.S. has heighted inspections. Hamburg explained that in order to keep people safe, these regulations are needed.

"Companies participating in both the pharmaceutical and drug roundtables said they were challenged by out heightened inspectional activities. 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," Hamburg wrote.

Hamburg's article can be accessed here.

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