US Food and Drug Administration has decided to conduct surprise inspections of drug manufacturing facilities outside the US, including units in India
US Food and Drug Administration will soon start unannounced onsite inspections of drug manufacturing facilities outside the US, including units in India. The USFDA had suspended most of its foreign inspections in March 2020 due to the covid-outbreak.
The US administration has decided to conduct surprise inspections of offshore manufacturing facilities to ensure quality products enter the US market. Besides, demand for surprise inspection at offshore facilities has also been on the rise from a section of Republican senators, who are seeking to offer a level-playing field to US manufacturers.
“Foreign pharmaceutical facilities are awarded significant lead time between the time they are notified of a facility inspection and the time the inspections take place. Domestic facilities do not receive the same treatment, receiving little to no advance notice prior to a facility inspection,” wrote Joni Ernst, junior US senator from Iowa. On 13 January, she introduced a bill, Creating Efficiency in Foreign Inspections Act, which seeks to move pharma units back to the US to strengthen the supply chain. Over 40% of generic drugs for the US is imported from India and China, which is a also a major source of active pharmaceutical ingredients used in manufacturing drugs.
