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US FDA to increase inspections of drug manufacturing units in India

US FDA to increase inspections of drug manufacturing units in India

US FDA to increase inspections of drug manufacturing units in India

US FDA to increase inspections of drug manufacturing units in India

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  • In 2023, the FDA conducted over 200 inspections in India, resuming unannounced inspections after a pandemic lull.
  • The FDA is requesting more drug investigators to be stationed in India.
  • The FDA emphasizes the need for increased investment in automation and enhanced resources for improved industry monitoring.
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A top executive for the Food and Drug Administration (FDA) informed Reuters that the US drug regulator plans to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over drug quality.

In 2023, the FDA conducted more than 200 inspections in India, resuming unannounced inspections after a lull during the pandemic.

“We are putting every effort into increasing the number of inspections … (and) requesting more drug investigators to be stationed here,” FDA Country Director (India) Sarah McMullen said on Tuesday.

The development arises as India’s $ 42 billion pharmaceuticals industry strives to expand its global presence, with the government urging drug producers to adopt good manufacturing practices to meet global standards.

Last year, the World Health Organization linked the deaths of dozens of children in Gambia to drugs manufactured in India. India’s total pharmaceutical products exports are dominated by the United States, accounting for 30 percent.

McMullen emphasized that the Indian pharma industry must increase investment in automation to achieve better compliance. He added that while the Indian government is investing in the expanding pharmaceutical industry, there is also a need to invest in enhancing the resources of the country’s drug regulatory body for improved monitoring of the industry.

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