RE:RE:USA Inflation Reduction Act (IRA) 2022 Re: Biotech and China Feb 27 (Reuters) - The U.S. drug regulator is set to increase the number of inspections at Indian drug manufacturing units in 2024 amid growing concerns over the quality of drugs, a top executive for the Food and Drug Administration (FDA) told Reuters.
The FDA conducted more than 200 inspections in 2023 in India, picking up after a lull in unannounced inspections 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 comes as India's $42-billion pharmaceuticals industry works to grow its global presence, with the government pushing drug producers to implement good manufacturing practices to match global standards. The World Health Organization last year had linked the deaths of dozens of children in Gambia to India-made drugs. The United States accounts for 30% of India's total pharmaceutical products exports.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-boost-inspections-drug-manufacturing-units-india-2024-02-27/