FDA invites Indian regulators to join inspections

Founder and Group Managing Director Veeda Clinical Research Private Limited Apurva Shah with Assistant Country Director US FDA India office Solomom Yimam (right) at the four-day BioAsia-2015 in Hyderabad on Wednesday. Photo: Mohammed Yousuf   | Photo Credit: Mohammed_Yousuf

The US Food and Drug Administration (FDA) India Office has invited officials of drug regulatory body, 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 Indian government had made requests to allow its officials to be present during inspections by the FDA. Many in the pharmaceutical industry also favour this.

On whether the agreement was being practiced, 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 that the US FDA in India operates out of New Delhi and Mumbai. It was looking to increase the headcount to 19. On what is the number now, he said probably 9-10 officials, but did not reply on whether more officials would mean more inspections.

The number of inspections, he added, was based on the marketing applications filed by pharma companies seeking to take its products to the US. On whether it pursues a target regarding the number of inspections, he said it was dependent on how many companies produce products meant for sale in the US.

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Printable version | Oct 26, 2020 4:03:07 AM | https://www.thehindu.com/news/cities/Hyderabad/fda-invites-indian-regulators-to-join-on-inspections/article6856283.ece

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