FDA Upping Drug Inspections in India: McMullen

FDA country director (India) Sarah McMullen says the agency will increase the number of inspections at Indian drug manufacturing facilities in 2024. Speaking with Reuters, McMullen said there were more than 200 inspections in the country in 2023, up from 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,” she told the news service.

The report says the U.S. accounts for 30% of India’s total pharmaceutical product exports. McMullen said the Indian drug industry needs to invest more in automation for better compliance. She added that while the country’s government is investing in the growing pharmaceutical industry, it also should be investing in growing the resources of the country’s drug regulators to better monitor the industry.