A Congressional committee in the United States has alleged that inspections carried out by the US Food and Drug Administration in China and India are “inadequate”, writing to the regulator that the countries demonstrate a “pattern of repeatedly violating FDA safety regulations”.
These violations included carcinogens being present in the medicines, destroying or falsifying data, and using non-sterile manufacturing processes, the letter said.
“Chinese and Indian manufacturers receive the most FDA warning letters,” it said.
It questioned the over-reliance of the country on imports from India and China, with 32% of all generic medicines and 45% of active pharmaceutical ingredients in the US coming from the two countries.
The committee also questioned the FDA on its foreign inspection policies, fewer in-person inspections conducted after pandemic restrictions were removed, and the number of inspectors available in different countries to conduct such inspections.
Citing data of inspections in China, the committee said, there were only 40 inspections conducted in the country 2020 through 2022 as compared to 131 inspections conducted in 2019 alone.
The committee also questioned why the regulator had stopped conducting unannounced inspections at manufacturing facilities despite a 2014-15 pilot in India proving to be beneficial.
The panel also questioned why the FDA maintained that it did not have oversight on the sourcing of active pharmaceutical ingredients and excipients despite it being required under good manufacturing practices of the country.
For India specifically, the committee asked the FDA why there was a dependence on Ahmedabad-based Intas pharmaceuticals for the supply of two chemotherapy drugs carboplatin and cisplatin despite the regulator being aware of “significant, repeated quality control failures.” The committee said that the Indian company was one of only five companies supplying the drug to the US.
The company decided to voluntarily halt production in the Ahmedabad plant due to the on-going quality control issues. The committee questioned why the FDA was not aware of this until the plant had shut down leading to a shortage of these drugs in the US market.
Intas said in a statement: “After an inspection of an Intas Pharmaceuticals, Ltd. manufacturing facility, Intas and Accord Healthcare, Inc., its US subsidiary, promptly made a voluntary decision to temporarily cease manufacturing and distribution of products manufactured at that facility for the US; Cisplatin and Carboplatin are two of these products.
Intas and Accord are committed to providing safe and effective, life-saving medicines for all patients. Patient safety will always be our primary focus. As part of that commitment, Intas and Accord worked with the FDA’s Drug Shortage Staff and the Office of Compliance to identify certain critical drugs that are medically necessary to continue to supply to the US market after further testing and verification. Cisplatin and Carboplatin have been determined to be medically necessary products. Working with the FDA, Accord will be releasing existing inventories of those products into the market.
In addition, Intas and Accord are working with the FDA on a plan to return to manufacturing. This allows for continued manufacturing of products that will be prioritized based on medical necessity.”