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Patients in the U.S. depend on medicines produced overseas. In fact, the U.S. imports 80 percent of all active pharmaceutical ingredients used in drugs consumed by U.S. patients and 40 percent of all finished drug products used in this country.[1] These percentages are likely to rise in the future.
To ensure that the drug products flowing into the U.S. from foreign manufacturers are safe, inspectors from the Food and Drug Administration (FDA) must have unfettered access to any foreign...
Patients in the U.S. depend on medicines produced overseas. In fact, the U.S. imports 80 percent of all active pharmaceutical ingredients used in drugs consumed by U.S. patients and 40 percent of all finished drug products used in this country.[1] These percentages are likely to rise in the future.
To ensure that the drug products flowing into the U.S. from foreign manufacturers are safe, inspectors from the Food and Drug Administration (FDA) must have unfettered access to any foreign drug factory making products destined for the U.S. Moreover, the agency must use its existing legal authority and conduct frequent, thorough inspections of these facilities, particularly in countries such as India and China, the latter of which has routinely prevented effective FDA inspections within its borders.
The importance of such inspections was highlighted by recent findings from an FDA inspection of a factory owned by Ranbaxy, a producer of numerous generic drugs prescribed in the U.S and one of the largest drug manufacturers in India. India is the second largest exporter of prescription and over-the-counter (OTC) drugs to the U.S., producing 40 percent of the generic prescription and OTC drugs consumed here.[2]
From Jan. 5 to Jan. 11, 2014, the FDA conducted an inspection of a Ranbaxy factory that produces active pharmaceutical ingredients in Toansa, India. FDA inspectors found numerous violations of good manufacturing practices intended to ensure the safety and quality of drug products.[3],[4] Most disturbing was the finding that staff at the Toansa facility repeatedly retested raw materials, intermediate products and final active pharmaceutical ingredients after those items had failed, or yielded suspect results on, tests for determining whether the products met required quality specifications.[5],[6] Retesting was done until acceptable results were obtained, and the failed or suspect test results were not reported.
Such fudging of critically important quality test results at different steps in the manufacturing process compromises the safety and quality of drugs made with active ingredients produced by Ranbaxy’s Toansa factory. Moving with unusual swiftness, the FDA, on Jan. 23, 2014, issued an order banning from the U.S. market any drugs manufactured using active ingredients from Ranbaxy’s Toansa factory and prohibiting the exportation of active ingredients from Toansa to the U.S. for any purpose.[7]
This is not the first time that the FDA has found serious problems at a Ranbaxy facility, and it likely will not be the last. To protect American consumers, the FDA must sustain an aggressive inspection regimen of all drug manufacturers in India, China and other countries where the quality of drug manufacturing standards is suspect.
References
[1] Food and Drug Administration. Global Engagement. http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/ucm298578.pdf. Accessed February 16, 2014.
[2] Harris G. Medicines made in India set off safety worries. The New York Times. February 14, 2014. http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html?hpw&rref=health&_r=0. Accessed February 16, 2014.
[3] Baker PE. Form FDA 483 for Ranbaxy Laboratories Limited, Village Toansa, India. January 11, 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf. Accessed February 16, 2014.
[4] Food and Drug Administration. News & Events: FDA press release. FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market. January 23, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm. Accessed February 16, 2014.
[5] Baker PE. Form FDA 483 for Ranbaxy Laboratories Limited, Village Toansa, India. January 11, 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/UCM382514.pdf. Accessed February 16, 2014.
[6] Food and Drug Administration. News & Events: FDA press release. FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market. January 23, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm382736.htm. Accessed February 16, 2014.
[7] Ibid.
