India Drug Regulator Vows Surprise Inspections For All Drug Makers
This article was originally published in PharmAsia News
Multinational drug makers as well as domestic ones can expect surprise visits by India drug inspectors at their local production facilities checking for violations of good manufacturing practices.
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One pilot target domestic manufacturers of finished drugs and another foreign manufacturers of APIs. As an incentive to participate, companies assigned high scores will be accorded regulatory flexibility. Also, participants that disclose facility ratings could “benefit from a competitive advantage.”