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.
“We are getting inputs from companies on the USFDA move,” said Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance, a lobby group of large generic drug companies.
In 2014, the FDA ran similar surprise inspections that led to many companies being served warning letters and alerts.
Law firm Sidley Austin LLP said in research note that during the 2014 pilot programme regulatory action against Indian drug manufacturers had increased by 60%.
The bill proposes an amendment to Section 704 of the US Federal Drugs and Cosmetics Act to include an addendum saying that an officer conducting inspections on locations outside the US “shall not notify the owner or operator of such establishment of the planned inspection before the inspection occurs”.
Exceptions will be made in case laws of a country where the facilities are located make it mandatory to issue advanced notice, but even then, it should be given “minimum” time.
India and the US have wrestled with the issue of generic drug exports in the past, while lobbying from both sides on supply chain diversification intensified when the Trump administration was in office.
The former US President’s ‘Make in America’ pitch had targeted both Indian and Chinese drug manufacturers. But following the covid outbreak, Indian generic drug companies stepped up supply to meet increasing demand of medicines in the US market, including essential covid medications such as hydroxychloroquine. According to USFDA database, there is a shortage of over 164 drugs in the US.
