Drug regulators invited by US FDA to join inspections
15 February 2015 | News | By BioSpectrum Bureau
Drug regulators invited by US FDA to join inspections
A practice in the making: Indian officials to join US FDA inspecting teams
The central and state drug regulatory officials have been invited by the US FDA to accompany their teams inspecting pharma units in the country. This was stated by Mr Soloman Yimam, assistant country director, the US FDA India Office, while addressing sessions during the recently concluded BioAsia. The move comes after an MoU was signed between the two countries in Feb last year.
"Based on that MoU whenever we do GMP (Good Manufacturing Practice) inspections we invite DCGI (Drug Controller General of India) officials and State regulators to accompany us on the inspections," said Mr Yimam to a leading newspaper. Asked whether the process is being practiced, he said that there were glitches but it was what they are striving towards.
