The Food and Drug Administration is establishing a new set of guidelines for drugs banned from U.S. exports after FDA inspectors found drugs were re-tested to gain favorable ratings.
India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines
Drug quality concerns, such as those that have banned U.S. sales of generic medicines from several manufacturing plants in India, have spurred regulators to create a new unit to sharpen their oversight.
The Food and Drug Administration is establishing an Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand-name, generic and over-the-counter drugs. The FDA is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection.
The agency now collects such information only during inspections. The thrust of the effort would be to head off potential concerns before the agency wields penalties such as banning products from troubled factories.
India’s pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.
F.D.A. investigators are blitzing Indian drug plants. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed. More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants.
In the latest incident last month, a Ranbaxy Laboratories Ltd. facility was banned from U.S. exports after FDA inspectors found drugs were re-tested to gain favorable results after initial analyses failed.
Lawmakers in Congress are scheduled to hear from doctors, researchers and patient advocates Feb. 26 in a briefing on whether substandard generic drugs are reaching the U.S. medical system from overseas.