The United States Food and Drug Administration (USFDA), which is considered to be the most stringent authority Indian drug makers, have been following Good Manufacturing Practices, which is clear as per the continued rate of India’s generic export to the US. The FDA believes that many companies understand and have successfully implemented good manufacturing practices and also that appropriate action would definitely be taken, should there be any non compliance observed.
USFDA trusts Indian GMP
The United States Food and Drug Administration (USFDA), which is considered to be the most stringent authority Indian drug makers, have been following Good Manufacturing Practices, which is clear as per the continued rate of India’s generic export to the US. The FDA believes that many companies understand and have successfully implemented good manufacturing practices and also that appropriate action would definitely be taken, should there be any non compliance observed.
According to the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the FDA needs to achieve the same inspection schedule for foreign facilities as domestic manufacturers. They will also have to clear of all the pending applications by the end of the first five-year user fee authorization period. They may consider having additional inspectors for the same as it will help in meeting the legislative mandates.
The FDA aims at converting from a domestically focused agency to a global health agency as trade and product performance understand no borders. With this in view, there are offices and post being opened across the globe and even in India.