Inspections: FDA invites Indian regulators to join

The US Food and Drug Administration (FDA) India office invited officials of drug regulators, both at Central and State government levels, to accompany its team inspecting pharmaceutical units in the country.

This is subsequent to a memorandum of understanding that the two countries inked during the visit of US FDA Commissioner to India in February 2014, according to Soloman Yimam, Assistant Country Director, US FDA India Office.

“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,” he said on Wednesday. Mr. Yimam, speaking on the sidelines of the BioAsia 2015 event here, was responding to a query on whether government of India has made requests to allow its officials to be present during inspections by FDA. Many in the pharmaceutical industry also favour this.

On whether the agreement was being practised, Mr. Yimam said: “There might be some glitches here and there, but it is something we always strive for… to bring them [Indian officials] on board. [We want them] to come with us, do the inspection, observe so that they can learn from our processes.”

Mr.Yimam, who addressed sessions at the Bio Asia on Tuesday as well as Wednesday, said the US FDA in India operates out of New Delhi and Mumbai. It was looking to increase the headcount to 19. It has 8 inspectors now.