To back surprising USFDA oversight

The US Administration has decided to conduct surprise inspections of offshore manufacturing facilities to ensure quality products enter the US market. In addition, there is growing demand for surprise inspections of offshore facilities from a section of Republican senators who are demanding equal opportunities for American manufacturers.

“Foreign pharmaceutical facilities are awarded a significant lead time between the time they are notified of a facility inspection and the time the inspection takes place. Domestic facilities,” wrote Joni Ernst, junior U.S. Senator from Iowa. does not receive equal treatment, no advance notice before a facility inspection.” On January 13, he introduced a bill, the Creating Efficiency in Foreign Inspection Act, which seeks pharma units to strengthen supply chains. More than 40% of generic drugs for the US are imported from India and China, which is also a major source of active pharmaceutical ingredients used in the manufacture of drugs.

Sudarshan Jain, general secretary of Indian Pharmaceutical Alliance, a lobby group for large generic drug companies, said, “We are getting inputs from companies on the USFDA move.

In 2014, the FDA conducted similar surprise inspections that led to several companies being given warning letters and alerts.

Law firm Siddeley Austin LLP said in a research note that there was a 60% increase in regulatory action against Indian drugmakers during the 2014 pilot program.

The bill proposes an amendment to section 704 of the US Federal Drugs and Cosmetics Act that includes an addendum that states that an officer conducting an inspection at locations outside the US “owns or will not inform the operator.”.

Exceptions will be made to the law of the country where the facilities are located, mandating the issuance of advance notice, but even then, it must be given a “minimum” time.

India and the US have wrestled in the past over the issue of generic drug exports, while lobbying from both sides over 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 makers. But after the Covid outbreak, Indian generic drug companies increased supplies to meet the growing demand for drugs in the US market, including essential COVID drugs like hydroxychloroquine. According to the USFDA database, there are more than 164 drug shortages in the US.