印度制药厂供应美国一半的仿制药, 面临FDA调查,
Indian drug plants supplying half U.S. generics face FDA probe over falsified data, poor conditions, and patient deaths.
提供美国近一半非专利药物的印度制药厂正在接受调查,因为报告显示数据伪造、文件销毁和制造条件差等现象十分普遍。
Indian pharmaceutical plants supplying nearly half of America’s generic drugs are under investigation after reports reveal widespread data falsification, document destruction, and poor manufacturing conditions.
根据FDA记录和特伦甘纳邦现场实地考察,调查人员发现反复违规行为,包括伪造实验室结果、不卫生环境以及隐瞒证据的努力。
Based on FDA records and on-site visits in Telangana, investigators found repeated violations including falsified lab results, unsanitary environments, and efforts to conceal evidence.
林业发展局前检查员Peter Baker说,尽管有大量文件证明,并证实病人死亡与有缺陷的药物有关,但低于标准的生产仍很普遍。
Former FDA inspector Peter Baker stated that substandard production is common despite strong documentation and confirmed patient deaths linked to faulty drugs.
调查结果引起了人们对美国毒品供应链安全的严重关切,突出说明了监督和问责方面的系统性缺陷。
The findings raise serious concerns about the safety of the U.S. drug supply chain, highlighting systemic flaws in oversight and accountability.