A recent RAPS Focus review of US FDA inspection reports conducted in China and India reveals a number of data and quality deficiencies that are raising alarms in the US pharmaceutical community. According to the report, 42 Indian drug manufacturing sites are currently on the FDA’s import watch alert, along with 41 sites in China and 5 in Hong Kong. This is a serious issue given that China and India produce around 80% of the world’s active pharmaceutical ingredients (APIs).
The Focus report highlights two main problems that are affecting the quality of APIs produced in China and India:
- The lack of FDA inspectors in China and India is making it difficult for the US agency to monitor overseas manufacturing facilities. In Beijing, the FDA has around 17 inspectors who are responsible for around 700 API manufacturing plants throughout China. The FDA attributes the lack of inspectors in China to increasingly stringent visa issues that make it difficult to send new employees abroad. In India, there are currently only 10 inspectors responsible for monitoring over 500 manufacturing sites.
- In addition to the lack of qualified inspectors, the Focus report found that manufacturers in China and India often manipulated data findings and filed incomplete lab results, among other violations.
In 2015, FDA inspectors carried out 132 inspections in China and 203 inspections in India.