FDA Investigates Indian Drugs Following Safety and Quality Concerns


The Food and Drug Administration (FDA) is placing Indian drug makers under increasing scrutiny following growing concerns about the safety of medications imported to the U.S. According to a report from The New York Times, 40% of over-the-counter and generic prescription drugs in the U.S. come from India.

The FDA commissioner traveled to India this week to discuss how to strengthen production safety and quality with Indian regulators, according to an FDA press release. The FDA has ramped up inspection of Indian drug manufacturing plants over the past several years as well, inspecting 160 plants last year – nearly triple the number they inspected in 2009.

Indian drug makers have faced multiple problems in recent years, including safety issues in manufacturing plants and the distribution of fake medicines. Recently, the FDA banned exports of generic versions of medications such as the acne drug Accutane and the common antibiotic Cipro, after they were found to be adulterated. The World Health Organization reported that in 2002, an estimated one in five medications in India’s major cities were counterfeit. Other medications have found to be substandard or lack any active ingredient.

While many drug plants in India meet U.S. standards, some Indian companies have paid huge fines after plants were found to have significant violations, including fly infestations. Nearly half of the warning letters issued by the FDA last year went to Indian companies.

India exports $15 billion worth of drugs a year, and increased U.S. regulation has the potential to take a large toll on the drug market in India as well as impact the U.S., The New York Times stated.