FDA resumes inspections of Indian and Chinese drug facilities, including ones that were on import bans
Since China contracted Covid-19 in 2020, its borders have been closed to most foreigners. That includes Food and Drug Administration inspectors investigating pharmaceutical manufacturing facilities that export drugs to the U.S. Now, the FDA appears to be resuming foreign inspections.
The Government Accountability Office (GAO) said in a report in February that “more than 50% of manufacturers supplying the U.S. market are located overseas—many in India and China.” The report heavily criticized FDA’s foreign drug inspection program, citing the many challenges facing the agency and the fact that its foreign inspections are preannounced.
Based on the FDA’s inspections database, around 15 mainland China labs were inspected between 2021 and July 16, 2022. Of the total, the FDA placed three companies on an import alert, and Xinxiang Tuoxin Pharmaceutical Company and Henan Lihua Pharmaceutical Company were both restricted of shipping of an anti-neoplastic drug used in chemotherapies in January 2021. Henan Lihua is also one of the world’s leading producers of prednisolone, a steroid medication used to treat certain types of allergies, inflammatory conditions, autoimmune disorders, and cancers.
On August 1, 2022, the FDA put Beijing Xinggu Lvsan Technology Co on import alert for numerous drugs after an inspection at their facility in April.
The FDA issued a Warning Letter to Hubei Kangzheng Pharmaceutical Company to a Chinese lab on November 23, 2021. However, this does not stop the company from exporting to the United States and it does not result in the FDA testing its drugs prior to being given to patients. The Warning Letter flagged the Chinese manufacturer for significant violations of Current Good Manufacturing Practice (CGMP), including failing to establish procedures to prevent microbial contamination of its over-the-counter ophthalmic redness reliever drops.
In the last five years, the FDA has refused shipments from some of these companies, like Henan Lihua, and others have received a Warning Letter. China was on the receiving end of the most shipment bans, but the FDA also issued a Warning Letter to India’s generics giant Aurobindo on January 12, 2022.
FDA did conduct at least 12 inspections in India for vaccines and drug quality assessments from January 2021 to June 30, 2022. The FDA gave three companies an Official Action Indicated (OAI), which means regulatory and/or administrative actions will be recommended. The rest received a Voluntary Action Indicated (VAI) grade, which means the FDA found objectionable conditions or practices. OAIs often lead to Warning Letters and Import Alerts.
The FDA also resumed inspections in China. Most of the Chinese drug companies are manufacturing non-branded drugs or active pharmaceutical ingredients (API) that get turned into pills, liquid medication, or injectables later branded by a Western drug company.
The global API market was valued at $193 billion in 2021 and is expected to expand at a growth rate of 5.55% over the next five years hitting around $266.9 billion by 2027. China is eyeing this market and looking to take away market share from India, its only real competitor at this point. Chinese companies account for 4 out of the top 10 generic drug manufacturers.
The biggest API makers are:
North China Pharmaceutical Group (China)
Zhejiang Medicine (China)
Johnson & Johnson (USA)
Dr. Reddy's Laboratories (India)
Lonza group (Swiss)
Haerbin Pharmaceutical Group (China)
Jiangsu Hengrui Medicine (China)
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.