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Global Processing e-News / Pharmaceutical / North America

US, Indian officials meet to discuss drug safety

February 17, 2014
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India and the United States have been locked in a regulatory conflict over generic pharmaceutical products distributed on the U.S. market. The Food and Drug Administration (FDA) has been tightening its grip on Indian manufacturers, resulting in import bans on a number of products produced by big Indian companies, the Wall Street Journal reports.

The ban that had the most serious implications for the market was the enforcement action taken against Ranbaxy. According to FDA officials, one of its facilities failed to meet the best industry standards and workers at the plant repeatedly manipulated test results. The import ban is just a measure aiming to ensure U.S. consumers are protected, the federal agency claimed.

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But Indian authorities do not seem to share this opinion. Both drug makers and officials have claimed that their pharmaceutical production was safe and noted that the FDA paid too much attention to "minor flaws" in the process. Some Indian industry representatives have even stated that the FDA was trying to keep cheaper generic products away from the U.S. market for commercial reasons.

In a meeting to discuss the matter, FDA Commissioner Margaret Hamburg and Indian trade minister Anand Sharma talked about safety standards in the pharmaceutical industry, the Wall Street Journal said. Commenting after the meeting, FDA spokeswoman Erica Jefferson said that U.S. officials were not trying to block Indian drug makers' access to the American market and pointed out that the agency was fully aware of the fact that most Indian producers were compliant with the manufacturing requirements.

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