US House Slams India-China for Violating FDA Regulations

A Congressional committee in the United States has alleged that inspections by the US Food and Drug Administration carried out in India and China are “inadequate”. They have written to the regulator that India and China have repeatedly violated Food and Drugs Administration’s safety regulations. According to the letter, the violation includes carcinogens being present in the medicines. Further it alleges about destroying or falsifying data and using non-sterile processes for manufacturing. The letter further states that India and China have received the most FDA warning letter The committee questioned the over-reliance of the US on imports from India and China, with 32% for generic medicines and 45% for active pharmaceutical ingredients. FDA was also questioned on its foreign policies as fewer in-person inspections were conducted after pandemic restrictions were removed and also the number of inspectors were reduced in India and China. The committee cited the data that only 40 inspections were conducted in China from 2020 to 2022, comparing it with 131 inspections conducted in 2019. The committee also questioned why the FDA had stopped conducting unannounced inspections at manufacturing facilities. For India, the committee asked the FDA about 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 repeated quality control failures. The committee further questioned why FDA was not aware about the voluntary shut down of the Ahmedabad plant which led to shortage of drugs in the US market.

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