US FDA to boost inspections of drug manufacturing units in India

By Thomson Reuters Feb 27, 2024 | 8:11 AM

By Rishika Sadam and Leroy Leo

(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.

McMullen said the Indian pharma industry needs to invest more in automation for better compliance.

While the Indian government is investing in the growing pharmaceutical industry, what is also necessary is investment in growing the resources of the country’s drug regulatory body for better monitoring of the industry, McMullen added.

(Reporting by Rishika Sadam and Leroy Leo in Hyderabad; Writing by Kashish Tandon; Editing by Sohini Goswami)