The US FDA is under fire due to one of its own reports. When the committee formed for the campaign to test medicines in India and China from January 2014 to April 2024 examined the results of the test, many irregularities were found.

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A report by the US Food and Drug Authority (FDA) has caused a ruckus. The FDA is a federal agency of America whose job is to approve medicines and check their quality. However, the investigation report of the agency itself has come under question. When a committee investigated the results of the report, it was found that there was a large-scale manipulation in it. The matter has reached a point that US lawmakers have written a letter to the commissioner of the agency.

In fact, the FDA had investigated medicines in India and China from January 2014 to April 2024, the results of which were quite surprising. There was a lot of difference in the results of the investigation. While many FDA inspection officers did not find any fault, there were many who filed complaints regarding compliance with the rules in both the countries. In a letter to the agency’s commissioner Robert Califf, the lawmakers wrote that the difference in the results has exposed the institutional weaknesses in the FDA’s foreign drug inspection program.

Big differences in testing

Some FDA inspectors found compliance problems in all or nearly all of their inspections in the two countries. Other inspectors rarely reported finding any problems. Two inspectors found no noncompliance issues during a total of 24 inspections in India. Another inspector found zero compliance issues in 20 of 23 inspections in China, or 85 percent, while finding compliance issues in nearly half of domestic inspections during the same period. Lawmakers called these results unusual because drug manufacturing and quality have been questioned in China and India.

Committee calls for investigation of report

In contrast, 16 FDA inspectors, collectively conducting more than 325 inspections in India, found compliance problems in every one of them. As a measure of what a pattern of rigorous inspections should look like, the committee reviewed the inspection results of 3 FDA inspectors with professional reputations who conducted at least 10 inspections in China or India during the study period. These expert inspectors reported no compliance issues during their inspections, with rates ranging from just 6.7 to 11.4 per cent in China and zero to 9.5 per cent in India. The Committee has called for further investigation into this.